This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis (NCT01962987), a randomized phase 3 study. The primary outcome is Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01962987 |
| Phase | Phase 3 |
| Condition | Actinic Keratosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 476 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Actavis Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with actinic keratosis were enrolled. The primary outcome is described for the Per-Protocol Population, but the registry record does not report demographic details, eligibility criteria, or how participants entered that analysis population.
Intervention
The test treatment was diclofenac sodium gel 3% from Actavis. Its arm description says the gel was applied to lesion areas twice daily and smoothed gently onto the affected skin.
Comparator
The active reference was Solaraze, diclofenac sodium gel 3% from Fougera Pharms. A vehicle gel placebo group was also included. The registry record describes the study as placebo-controlled.
Primary question
The primary measure concerns the proportion of patients with 100% clearance of all actinic keratosis lesions in the treatment area at Day 90. The stated purpose of this measure was to evaluate bioequivalence between the test formulation and the reference formulation. Outcome results and the criteria used to determine bioequivalence are not reported in the registry record.
In statistical terms, the comparison is about a complete-clearance outcome at a specified assessment time, not about the average change in lesion count. Complete clearance is a strict response definition: a participant either meets that definition or does not, as recorded for the outcome. The registry lists the outcome unit as participants and the parameter as a participant count, while its title describes a percentage of patients. Those descriptions indicate the response being assessed, but do not provide the observed count or percentage for any group.
The clinical question therefore has two parts: how the test gel performed relative to the active reference on the stated endpoint, and how the observed response compared with the placebo group. The record identifies these treatments and the assessment time, but does not report the numerical outcome data needed to answer either comparison. The endpoint description specifies the Per-Protocol Population; further details about who qualified for that population are not reported in the registry record.
3. Trial Design
The registry describes a randomized, double-blind, multiple-site, placebo-controlled, parallel-design Phase 3 study. Its stated enrollment was 476, and its status is completed. The study compared Actavis diclofenac sodium gel 3% with Solaraze diclofenac sodium gel 3%; the registry also lists a vehicle gel placebo group. The sponsor is Actavis Inc.
Random allocation means assignment to treatment groups was determined by a random process, according to the design label. Double masking indicates that the study was designed to keep treatment assignment concealed from participants and relevant study personnel, although the registry record does not specify exactly who was masked or how masking was maintained. In a parallel design, participants are assigned to a group and receive that group’s treatment rather than crossing over between treatments. These are general explanations of the design labels; further implementation details are not reported in the registry record.
The arm descriptions state that the test gel and reference gel were applied to lesion areas twice daily, smoothed gently onto the affected skin. The placebo description also specifies twice-daily application to lesion areas. The amount depended on the size of the lesion site, according to the descriptions. More complete details about treatment duration, adherence assessment, and concomitant care are not reported in the registry record.
The record lists a study start of 2013-03 and a primary completion of 2013-09. It does not provide a detailed account of recruitment, the number or characteristics of participating sites, or the timing of individual assessments beyond the primary outcome’s Day 90 timeframe. Although the study is described as placebo-controlled, the primary measure is specifically described as being used to evaluate bioequivalence of the test and reference formulations. The record does not state the planned comparison hierarchy or the statistical criteria for that evaluation.
Enrollment describes the stated study enrollment; it should not be mistaken for the number included in every analysis. In particular, the primary measure is explicitly described as using the Per-Protocol Population. The number of participants in that population and the reasons participants may have been excluded from it are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Diclofenac Sodium 3% Gel | Solaraze( Diclofenac Sodium) 3% Gel | Vehicle Gel |
|---|---|---|---|
| STARTED | 190 | 191 | 95 |
| COMPLETED | 160 | 163 | 83 |
| NOT COMPLETED | 30 | 28 | 12 |
Reasons for not completing this period:
| Reason | Diclofenac Sodium 3% Gel | Solaraze( Diclofenac Sodium) 3% Gel | Vehicle Gel |
|---|---|---|---|
| Adverse Event | 4 | 4 | 0 |
| Lost to Follow-up | 0 | 0 | 1 |
| Non compliance with dosing requirements | 4 | 2 | 0 |
| Miscellaneous | 1 | 9 | 2 |
| Restricted medication | 5 | 1 | 1 |
| Serious Adverse Event | 1 | 0 | 0 |
| Withdrawal by Subject | 11 | 10 | 6 |
| Randomized in Error | 4 | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: Analysis provided using the Per-Protocol Population.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Population
| Characteristic | Unit | Diclofenac Sodium 3% Gel | Solaraze( Diclofenac Sodium) 3% Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Participants analysed | 188 | 189 | 93 | 470 | |
| Age, Continuous | years | 65.34 (SD 11.42) | 66.24 (SD 11.37) | 65.55 (SD 11.00) | 65.71 (SD 11.26) |
| Sex: Female, Male: Female | Participants | 56 | 54 | 26 | 136 |
| Sex: Female, Male: Male | Participants | 132 | 135 | 67 | 334 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 21 | 19 | 8 | 48 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 167 | 170 | 85 | 422 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 188 | 189 | 93 | 470 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90, measured over 90 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Percentage of Patients With 100% Clearance of All AK Lesions Within the Treatment Area Assessed at Day 90.” In plain terms, it asks whether a participant had complete clearance of all actinic keratosis lesions in the specified treatment area at the Day 90 assessment. The record gives the unit as participants and the parameter as a count of participants. It also states that the primary measure of bioequivalence would be evaluated using patients who completed the study according to the Per-Protocol Population.
This is a binary outcome at the participant level: the endpoint records whether the complete-clearance definition was met. That is a general description of how a yes-or-no endpoint works; the registry record does not report the outcome values. While the title uses “percentage,” no group-specific percentage or participant count for this outcome appears in the record. The result is therefore not reported in the registry record.
As a general statistical rationale, complete clearance can provide a direct measure of whether a prespecified treatment goal was reached, rather than describing a partial change in lesion burden. That makes the response definition important: a participant with some improvement but without full clearance would not meet the endpoint as worded. Whether this endpoint was considered clinically meaningful by investigators, and how it was selected, are not reported in the registry record.
The endpoint is useful for assessing the stated comparison only when paired with the analysis plan and observed results. The registry record identifies the assessment time and analysis population, but does not report the bioequivalence margin, group results, an effect estimate, or its uncertainty. As a result, the endpoint definition can be described, but the degree of similarity between formulations cannot be assessed from the information reported.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its assessment at Day 90, but does not report the outcome results. No group-specific clearance counts or percentages, treatment contrast, confidence interval, or p-value for this endpoint are reported in the registry record. Consequently, the posted information does not establish the direction or size of any difference in complete clearance, nor how precisely such a difference was estimated.
The intended primary comparison concerns Actavis diclofenac sodium gel 3% and Solaraze diclofenac sodium gel 3%. The registry says the primary measure was to evaluate bioequivalence and identifies the Per-Protocol Population for that evaluation. The presence of an active reference formulation is central to that stated question. The vehicle gel placebo is also part of the study, but the record does not specify the statistical role assigned to each comparison or whether the placebo comparison was primary, secondary, or descriptive.
Bioequivalence is not established merely because two treatments have similar-looking observed results or because a conventional difference test is not statistically significant. As a general statistical principle, an equivalence assessment requires a prespecified range of differences considered compatible with equivalence and an analysis that evaluates the estimate against that range. The registry record does not report such a margin, the method of analysis, or the estimate and uncertainty needed to assess the claim. No conclusion about bioequivalence can therefore be drawn from the outcome description alone.
The record states that the primary analysis used the Per-Protocol Population. This is relevant because an analysis restricted to participants meeting protocol requirements may differ from an analysis of everyone randomized. The record does not give the population size, participant flow, exclusion reasons, or a complementary analysis population for the primary endpoint. Without these details and the results, it is not possible to judge how the analysis population affected the comparison.
Safety information is reported separately from the primary efficacy outcome. The record lists serious and other adverse-event counts for the treatment groups and records zero deaths in each group. These entries describe reported safety counts; they do not supply a causal assessment or resolve the missing primary outcome information.
The registry record also identifies a reason that the primary outcome was not reduced to one comparison: it has several categories or time points. No category-specific outcome results are included in the information reported. Thus, the available record supports a description of the design and endpoint, but not a statistical interpretation of treatment effect or equivalence.
9. Statistical Methods Explained
The registry record identifies the outcome as binary and describes it as a count of participants with an event. For this endpoint, the event is complete clearance of all actinic keratosis lesions in the treatment area at Day 90. That means the underlying outcome is whether each participant met the complete-clearance definition. The title expresses the outcome as a percentage, but the record does not report group-specific event counts or percentages.
What does a binary endpoint tell the reader?
General: A binary endpoint reduces each participant’s outcome to whether a stated event occurred. A group’s event proportion describes how common that event was among participants included in the relevant analysis. Comparing proportions can summarize an absolute difference, a relative measure, or another contrast, depending on the planned method. These are distinct ways to describe data; the registry record does not report which treatment-effect measure was used for this endpoint.
For a complete-clearance endpoint, the definition determines what counts as an event. Partial clearance does not meet the endpoint as titled. This makes the outcome straightforward to interpret at the participant level, but it also means that the results depend on the definition and assessment process. The record states the treatment area and Day 90 timeframe, but further details about lesion assessment, assessor procedures, and handling of ambiguous assessments are not reported in the registry record.
What would an uncertainty interval mean?
General: A confidence interval describes the range of effect estimates compatible with the observed data under the assumptions of the statistical method. A narrow interval indicates greater precision than a wide interval, while an interval that includes values on both sides of a decision boundary may leave the conclusion uncertain. The interval does not remove uncertainty or guarantee that the true effect lies within its limits. No confidence interval for the primary endpoint is reported in the registry record.
For an equivalence question, uncertainty needs to be interpreted relative to a prespecified equivalence margin. General: the point estimate alone is not enough; the uncertainty around it must be assessed against the range regarded as acceptable under the study’s criteria. The registry record states that the primary measure was intended to evaluate bioequivalence, but the margin, interval method, and decision rule are not reported. The posted information therefore cannot show whether the study met an equivalence criterion.
What is the role of the analysis population?
The primary endpoint description specifies the Per-Protocol Population. General: a per-protocol analysis generally focuses on participants who satisfy defined protocol requirements, whereas an analysis based on all randomized participants addresses a different analysis population. These populations can produce different estimates if exclusions or deviations are related to outcomes or treatment. The record does not define the protocol requirements for inclusion, report the population size, or give participant flow for this endpoint. It also does not report whether another analysis population was used as a supporting analysis.
What can be inferred from the planning assumptions?
The sample-size assumptions are described as a planning illustration based on the observed effect, not as the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such illustrations can show how a hypothetical future study’s size depends on assumptions about effect and precision. They are not observed power, do not describe the study’s actual enrollment rationale, and do not establish that the trial was adequately sized for its primary question. The registry record does not report the original sample-size justification or the values needed to assess a design calculation.
General: power is a design property calculated under assumptions about the effect, variability or event rate, significance criterion, and analysis. It is not a measure of how likely the observed result is true, and it should not be calculated retrospectively from the observed effect as though it were evidence of success. Any planning illustration based on the observed effect should be read as an illustration of assumptions, not as observed power. No additional sample-size calculations or underlying primary-outcome effect values are reported in the registry record.
Which statistical procedures were used?
The specific statistical test, model, adjustment strategy, confidence-interval procedure, and equivalence decision rule are not reported in the registry record. No interim analyses or stopping criteria are reported. General statistical explanations of possible methods should not be mistaken for a description of procedures used in this study. With the method and primary outcome results absent, the record supports an account of the endpoint and intended question, but not reconstruction of the analysis or independent verification of a conclusion.
10. Multiplicity, Missing Data and Analysis Populations
The registry record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. It does not provide the category-specific or time-specific outcome results, so the effect of those multiple outcome dimensions on interpretation cannot be assessed from the record. It also does not report a testing hierarchy, a multiplicity adjustment, or which comparisons were designated as confirmatory.
General: when multiple hypotheses or outcomes are tested, the chance of at least one apparently positive result can increase if each is assessed independently using the same decision threshold. Prespecifying a hierarchy or applying an adjustment can address some multiplicity concerns, but the appropriate approach depends on the trial question and analysis plan. No such approach is reported in the registry record; it should not be assumed that an adjustment was or was not used.
The primary outcome description identifies the Per-Protocol Population. The record does not report how missing Day 90 assessments were handled, whether participants with missing outcomes were excluded, or whether sensitivity analyses were performed. It also does not give the numbers or reasons for missing outcomes or protocol deviations. Those omissions matter because the analyzed participants and the handling of unavailable outcomes can affect an estimate.
Enrollment was 476, but the record does not provide the primary analysis population size or participant disposition for this endpoint. It lists two analyses without describing their methods or relationship. The registry record does not report whether results were also evaluated in an intention-to-treat population. Without the analysis-population details, missing-data strategy, and multiplicity plan, the robustness of any primary conclusion cannot be evaluated. No assumptions about these procedures should be inferred from the design labels alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Diclofenac Sodium 3% Gel | 7 | 188 | 3.7% |
| Solaraze( Diclofenac Sodium) 3% Gel | 4 | 189 | 2.1% |
| Vehicle Gel | 2 | 93 | 2.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Diclofenac Sodium 3% Gel | 0 of 188 |
| Solaraze( Diclofenac Sodium) 3% Gel | 0 of 189 |
| Vehicle Gel | 0 of 93 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Diclofenac Sodium 3% Gel | 102 of 188 |
| Solaraze( Diclofenac Sodium) 3% Gel | 91 of 189 |
| Vehicle Gel | 35 of 93 |
Most frequent serious adverse event terms
| Event term | Organ system | Diclofenac Sodium 3% Gel | Solaraze( Diclofenac Sodium) 3% Gel | Vehicle Gel |
|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | 0 of 188 | 2 of 189 | 0 of 93 |
| Cardiac disorder | Cardiac disorders | 1 of 188 | 0 of 189 | 0 of 93 |
| Vertigo | Ear and labyrinth disorders | 0 of 188 | 0 of 189 | 1 of 93 |
| Nausea | Gastrointestinal disorders | 1 of 188 | 0 of 189 | 0 of 93 |
| Bacteraemia | Infections and infestations | 0 of 188 | 1 of 189 | 0 of 93 |
| Cardiac myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 188 | 0 of 189 | 0 of 93 |
| Cerebrovascular accident | Nervous system disorders | 1 of 188 | 0 of 189 | 0 of 93 |
| Presyncope | Nervous system disorders | 1 of 188 | 0 of 189 | 0 of 93 |
| Syncope | Nervous system disorders | 1 of 188 | 0 of 189 | 0 of 93 |
| Alcoholism | Psychiatric disorders | 1 of 188 | 0 of 189 | 0 of 93 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Diclofenac Sodium 3% Gel | Solaraze( Diclofenac Sodium) 3% Gel | Vehicle Gel |
|---|---|---|---|---|
| Headache | Nervous system disorders | 5 of 188 | 7 of 189 | 3 of 93 |
| Application site dermatitis | General disorders | 6 of 188 | 3 of 189 | 0 of 93 |
| Dizziness | Nervous system disorders | 2 of 188 | 2 of 189 | 2 of 93 |
| Nausea | Gastrointestinal disorders | 2 of 188 | 1 of 189 | 2 of 93 |
| Application site pain | General disorders | 2 of 188 | 1 of 189 | 2 of 93 |
| Application site pruritus | General disorders | 2 of 188 | 2 of 189 | 1 of 93 |
| Bronchitis | Infections and infestations | 0 of 188 | 1 of 189 | 3 of 93 |
| Atrial fibrillation | Cardiac disorders | 3 of 188 | 0 of 189 | 0 of 93 |
| Intestinal obstruction | Gastrointestinal disorders | 0 of 188 | 2 of 189 | 1 of 93 |
| Application site exfoliation | General disorders | 0 of 188 | 3 of 189 | 0 of 93 |
Serious events with the highest arm-level rate: vertigo (1.1%), angioplasty (1.1%), intestinal obstruction (1.1%), cardiac disorder (0.5%), nausea (0.5%).
The registry reports serious adverse events among 188 at risk in the Diclofenac Sodium 3% Gel group, with 7 affected; among 189 at risk in the Solaraze (Diclofenac Sodium) 3% Gel group, with 4 affected; and among 93 at risk in the Vehicle Gel group, with 2 affected. It reports other adverse events with 102 affected among 188 at risk, 91 among 189 at risk, and 35 among 93 at risk, respectively. The record lists zero deaths in each group.
These are group-level counts, not evidence that a treatment caused an event. The registry record does not provide event-level timing, exposure-adjusted rates, severity grading for other events, or a causal assessment. The at-risk denominators should be read alongside the affected counts; they are not the stated enrollment total for the study.
The record also lists serious-event terms with percentages: Vertigo, 1.1%; Angioplasty, 1.1%; Intestinal obstruction, 1.1%; Cardiac disorder, 0.5%; Nausea, 0.5%; and Cardiac myxoma, 0.5%. It does not identify the treatment group for each listed term in this summary. These entries should not be interpreted as comparative treatment effects or as a complete description of safety. The figures describe what the registry reports, while the context needed to interpret individual events is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, double-blind, parallel-design Phase 3 study compared Actavis diclofenac sodium gel 3% with Solaraze diclofenac sodium gel 3%, with a vehicle gel placebo group also listed. Its primary measure was complete clearance of all actinic keratosis lesions in the treatment area at Day 90, assessed in the Per-Protocol Population. The stated aim of that measure was evaluation of bioequivalence between the test and reference formulations.
The record does not report the primary outcome results. It therefore does not show how many participants met the complete-clearance definition, the percentage in each group, the size or direction of any comparison, or the precision of an estimate. It also does not report the equivalence margin or statistical decision rule. The study’s stated aim should not be mistaken for evidence that the aim was achieved; no conclusion about bioequivalence can be drawn from the information reported.
General: a randomized comparison can support an estimate of differences between assigned groups when its conduct, outcome data, and analysis are sufficiently described. A design label alone does not establish the result, precision, or reliability of an estimate. Here, the missing outcome values and methods prevent those assessments. The Per-Protocol Population specification also means the primary analysis is not automatically understood to include everyone randomized; participant flow and the implications of exclusions are not reported in the registry record.
The safety counts offer a separate descriptive record of serious and other adverse events, including the reported death counts. They do not, by themselves, establish that an event was caused by a study treatment, nor do they answer the primary efficacy or equivalence question. The posted information can describe the trial’s stated design, endpoint, and reported safety counts, but it cannot establish whether one formulation performed better, whether the formulations were equivalent, or how confident a reader should be in an efficacy conclusion.
13. Why This Trial Matters Statistically
This trial is statistically notable for the distinction between a study’s stated objective and the evidence needed to evaluate it. The registry identifies bioequivalence as the purpose of the primary measure, but the record does not report the results, equivalence margin, or decision rule. Those details are essential to interpreting an equivalence question: observing no statistically significant difference would not, by itself, establish equivalence. General: equivalence depends on whether the estimate and its uncertainty meet prespecified criteria.
The endpoint is a complete-clearance response at Day 90, described as a participant count and titled as a percentage. That makes the outcome definition and the analysis population important to interpretation. The record specifies the Per-Protocol Population, but does not describe its membership, participant flow, or missing-outcome handling. Readers cannot assess whether the analyzed participants represent the randomized groups or how protocol deviations affected the reported analysis.
The study also includes an active reference and a vehicle gel placebo group. This design can address more than one kind of question, but the registry record does not describe a hierarchy among comparisons or how multiplicity was handled. The primary endpoint is additionally noted as having several categories or time points, without category-specific results. This combination of missing results and analysis details limits what can be inferred from the registration information.
Finally, the sample-size assumptions are explicitly described as a planning illustration based on the observed effect rather than the trial’s own design. Keeping planning illustrations separate from observed power is important: a hypothetical calculation cannot substitute for a prespecified design justification or for estimates with uncertainty. Taken together, these features make the record useful for identifying the study question and design, while leaving the central efficacy and equivalence conclusions unevaluable from the reported information.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary outcome is named and timed, but its numerical results are not reported in the registry record. Without group-specific counts, percentages, treatment contrasts, or uncertainty intervals, the outcome cannot be interpreted as evidence for or against a difference. The stated bioequivalence purpose is also difficult to evaluate because the record does not report an equivalence margin, the statistical method, or the decision rule.
The primary analysis is described as using the Per-Protocol Population, but the record does not provide its size, eligibility rules, exclusions, or participant flow. It does not report how missing outcome assessments were handled, whether sensitivity analyses were conducted, or whether a complementary analysis population was used. These omissions prevent assessment of the effect of missing data and protocol deviations on the primary result.
The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not report how those categories were analyzed or whether multiplicity was addressed. The number of analyses is listed, but their identities and methods are not described. The record also does not report interim analyses, stopping rules, or the original sample-size justification.
Additional design and conduct details are limited. The record does not provide participant characteristics, detailed eligibility criteria, site-level information, treatment duration, adherence results, or a full account of outcome assessment procedures. Safety counts are reported, but further context for event timing, attribution, or exposure is not included in the summary information. These limitations concern what is reported in the registry record; they do not establish that the study itself lacked these procedures or data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis — NCT01962987.
- Registry record last updated 2020-07-20; status last verified 2020-07.
- Results first posted 2020-07-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01962987 is a completed randomized, double-blind, multiple-site, placebo-controlled, parallel-design Phase 3 study sponsored by Actavis Inc. Its stated enrollment was 476. It compared Actavis diclofenac sodium gel 3% with Solaraze diclofenac sodium gel 3%, and also included a vehicle gel placebo group. The study start is listed as 2013-03 and primary completion as 2013-09.
The primary outcome was complete clearance of all actinic keratosis lesions in the treatment area at Day 90, assessed in the Per-Protocol Population. The measure was intended to evaluate bioequivalence of the test and reference formulations. Outcome results, equivalence criteria, and detailed statistical methods are not reported in the registry record.
Safety entries report serious and other adverse-event counts by group and zero deaths in each group. The record also describes sample-size calculations as planning illustrations based on the observed effect, not the trial’s own design. The information reported supports description of the study design and endpoint, but does not permit assessment of the primary treatment comparison.