This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
CONSENSUS is a clinical study designed to evaluate the level of expert consensus on recommended pre- and post-procedure skincare protocols for aesthetic procedures.
| Feature | CONSENSUS |
|---|---|
| NCT ID | NCT07334353 |
| Status | Enrolling by invitation |
| Title | Consensus Guidelines for Pre- and Post-Procedure Skincare in Aesthetic Treatments |
| Lead sponsor | Venus Research Center |
| Sponsor type | Other |
| Conditions | Pre and Post Procedure Skin Care; Skin Care |
| Number of arms | 1 |
2. Clinical Question
Population
Experts participating in a Delphi study evaluating skincare recommendations surrounding aesthetic procedures.
Intervention / Assessment
Structured evaluation of expert agreement on pre- and post-procedure skincare protocols.
Comparator
The registry describes a single-arm study design.
Primary Question
What level of expert consensus exists regarding recommended skincare protocols before and after aesthetic procedures?
3. Trial Design
Delphi study evaluating expert consensus.
15 participants.
Single study arm.
Start date: 2026-05-01. Primary completion date: 2026-12-01.
4. Endpoints
| Endpoint | Definition | Time Frame |
|---|---|---|
| Level of Expert Consensus on Pre- and Post-Procedure Skincare Protocols for Aesthetic Procedures | The study aims to determine expert agreement on pre-procedure skin preparation measures, including barrier optimization, hydration, photoprotection, and topical priming agents; and post-procedure care including barrier repair, management of erythema or inflammation, photoprotection, and timing for reintroduction of active topical agents. | 6–8 weeks |
5. Planned Analysis
The registry identifies the primary outcome as the level of expert consensus on skincare recommendations. No results or formal statistical analyses are posted on ClinicalTrials.gov.
For a Delphi consensus study, the primary statistical focus is generally the quantification of agreement among expert respondents. Depending on the prespecified consensus definition, analyses may include agreement proportions, measures of dispersion, or changes in agreement across Delphi rounds.
Consensus measurement
A consensus endpoint differs from a conventional randomized clinical trial efficacy endpoint. The objective is not to estimate a treatment effect between groups, but to characterize the degree of agreement among experts regarding recommendations.
6. Statistical Methodology
Delphi methodology
The Delphi approach is a structured method for collecting expert opinions through repeated assessment and refinement. Statistical interpretation depends on how consensus is defined before analysis.
Single-arm design
Because the registry describes one study arm, the analysis framework focuses on describing expert agreement rather than comparing outcomes between randomized treatment groups.
Sample size considerations
The enrollment is 15 participants. In consensus research, sample size interpretation differs from hypothesis-testing trials because precision depends on the consensus metric and the variability of expert responses.
7. Statistical Methods Explained
Why is a Delphi design used?
A Delphi design is used when evidence may be incomplete or practice variation exists and expert agreement is the outcome of interest.
What is the statistical target of a consensus study?
The target is agreement among experts rather than a difference in clinical outcomes between intervention groups.
Why is there no treatment-effect estimate?
A treatment-effect estimate requires comparison groups or longitudinal outcome contrasts. A single-arm consensus study addresses a different statistical question.
Why must consensus criteria be prespecified?
The meaning of agreement depends on the threshold or statistical rule used to define consensus.
8. Limitations
- Single-arm design: The study is not structured to estimate comparative effects between groups.
- Expert sample size: Enrollment is 15 participants, which influences the precision and generalizability of consensus estimates.
- Consensus versus clinical outcomes: Agreement among experts does not directly establish clinical effectiveness of a skincare protocol.
- Definition dependence: Interpretation depends on the prespecified definition of consensus and analysis framework.
9. Why This Trial Matters Statistically
CONSENSUS illustrates how statistical methods are applied beyond traditional treatment-comparison trials. Many clinical questions involve establishing standards, measuring agreement, and reducing variation in practice.
| Concept | Application |
|---|---|
| Consensus measurement | Quantifying agreement among experts |
| Delphi methodology | Structured iterative expert assessment |
| Descriptive statistics | Summarizing expert responses |
| Study design | Single-arm evaluation of expert consensus |
10. Sources
- ClinicalTrials.gov: CONSENSUS (NCT07334353)