- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296588
Expert Consensus on Photoprotection Practices: A Delphi Study
Study Overview
Status
Detailed Description
This study is a non-interventional, methodological Delphi consensus project designed to develop standardized recommendations for photoprotection practices. Photoprotection encompasses strategies to minimize ultraviolet (UV)-related skin damage, including sunscreen use, clothing, behavioral measures, and patient education. Despite broad awareness campaigns, inconsistencies exist regarding SPF selection, application methods, timing, reapplication frequency, and the use of additional protective measures.
A steering committee of dermatologists and photoprotection experts will conduct a literature review and draft initial statements addressing key domains:
Sunscreen use: SPF level, spectrum coverage (UVA/UVB), formulation (chemical vs. physical), water resistance.
Application guidelines: Amount, timing before sun exposure, reapplication frequency, body coverage.
Adjunctive measures: Protective clothing, hats, sunglasses, shade-seeking behavior.
Special populations: Children, pregnant women, outdoor workers, patients with photosensitive dermatoses.
Behavioral counseling: Education strategies, adherence promotion, and misconceptions.
Integration with skin care and aesthetic practices.
A panel of experts in dermatology, photobiology, and related fields will participate in multiple Delphi rounds. Panelists will rate agreement with each statement using a Likert scale. Anonymized feedback will be provided after each round, and statements not reaching a predefined consensus threshold (e.g., ≥70-80%) will be revised and re-evaluated in subsequent rounds.
The final output will consist of consensus-based recommendations reflecting practical, safe, and evidence-informed photoprotection practices. Areas of disagreement or uncertainty will also be highlighted, identifying research gaps and priorities for future studies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Venus Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population will consist of a purposive sample of experts in dermatology, photobiology, and related fields who are actively involved in photoprotection research, clinical practice, or public health initiatives. Panelists should have experience advising patients or populations on sun protection, sunscreen use, and UV-related skin care.
Panel Size and Rationale:
Target enrollment: 20-35 experts
Sufficient to capture diverse perspectives while remaining manageable for multiple Delphi rounds.
Minimum for analysis: 15 panelists, ensuring representativeness in case of attrition
Description
Inclusion Criteria:
Board-certified dermatologists, photobiologists, or clinicians/researchers with ≥5 years of relevant experience.
Regular involvement in advising on photoprotection, skin cancer prevention, or UV-related dermatology.
Engagement in research, guideline development, teaching, or professional society activities related to dermatology, photobiology, or public health.
Willingness and availability to participate in all Delphi rounds.
Exclusion Criteria:
- Non-dermatology or non-photobiology specialists without relevant experience.
Less than 5 years of relevant clinical or research experience.
Limited or no experience with photoprotection counseling or research.
Significant undisclosed conflict of interest related to sunscreen or photoprotection products.
Inability or unwillingness to participate in all Delphi rounds.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Expert Panel
The study population will consist of a purposive sample of dermatologists, photobiologists, and other experts actively involved in photoprotection research, clinical practice, or public health initiatives. Panelists should have experience advising patients or the public on sunscreen use, UV protection strategies, or photodermatoses. Panel Size and Rationale: Target enrollment: 20-35 experts Large enough to capture diverse perspectives while remaining feasible for iterative Delphi rounds. Minimum for analysis: 15 panelists to ensure adequate representativeness in case of attrition. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary Outcome
Time Frame: 6-12 weeks
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Level of expert consensus on statements regarding photoprotection practices, measured as the proportion of panelists reaching the predefined agreement threshold (e.g., ≥70-80%) per statement across Delphi rounds.
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6-12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Secondary Outcomes
Time Frame: 6-12 weeks
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Consensus on sunscreen use: SPF level, broad-spectrum coverage, formulation, and water resistance. Consensus on application guidelines: amount, timing before sun exposure, reapplication frequency, body coverage. Consensus on adjunctive measures: protective clothing, hats, sunglasses, shade-seeking behavior. Consensus on special populations: children, pregnant women, outdoor workers, photosensitive patients. Consensus on behavioral counseling and education strategies for adherence. Identification of areas of uncertainty requiring further research or regional adaptation. |
6-12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Photoprotection-VRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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