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Enrolling By InvitationNCT07293793

Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
15 (estimated)
Sponsor
Venus Research Center · Academic / Other
Sex
All
Age
25 Years
Healthy volunteers
Accepted

Summary

This research presents a comprehensive consensus on pregnancy skin care, synthesizing expert recommendations to ensure maternal skin health while prioritizing fetal safety. It outlines safe and effective skin care practices tailored to the physiological and hormonal changes during pregnancy. Key guidelines emphasize the use of gentle cleansing, adequate hydration, mineral-based sun protection, and the selection of dermatologically safe ingredients such as vitamin C, hyaluronic acid, niacinamide, and azelaic acid. The consensus highlights the avoidance of potentially harmful substances including retinoids, high-dose salicylic acid, and certain chemical sunscreens. Additionally, the research provides clinical guidance on managing common pregnancy-related skin conditions and cautions against aggressive cosmetic procedures. The outcomes serve as a critical resource for dermatologists and healthcare providers to optimize skin care regimens during pregnancy, balancing efficacy with safety for both mother and child.

Detailed description

Background and Rationale Pregnancy is associated with profound hormonal, immunological, and metabolic changes that directly affect the skin. These changes can manifest as physiologic alterations (e.g., hyperpigmentation, striae), exacerbation of pre-existing dermatologic diseases, or pregnancy-specific dermatoses. Safe and effective skin care during pregnancy is critical, as many commonly used dermatologic ingredients cross the placental barrier, lack human safety data, or pose teratogenic risks. Despite the high prevalence of dermatologic concerns in pregnancy, current clinical guidance remains fragmented, variable across regions, and often based on expert opinion rather than standardized consensus. To address this gap, we employed a structured Delphi expert consensus process to develop evidence-informed, practical, and regionally adaptable guidelines for pregnancy-safe skin care. Methods: Delphi Consensus Process A structured three-round Delphi methodology was used to achieve consensus among a multidisciplinary panel of dermatologists, obstetricians, and pharmacology experts. 2.1. Panel Composition N = 25 experts Representatives from dermatology, maternal-fetal medicine, and clinical pharmacology Minimum of 5 years of clinical experience Geographic representation from MENA, Europe, and Asia Steps in the Delphi Process Round 1: Exploration Experts provided open-ended responses on: Essential principles of pregnancy-safe skin care Ingredient safety classifications Preferred management of common dermatologic conditions Cultural and regional care considerations A qualitative analysis was performed to derive core themes. Round 2: Structured Statements 75 draft statements were generated and rated using a 9-point Likert scale 1-3: Disagree 4-6: Uncertain 7-9: Agree Consensus defined as ≥ 75% of experts rating 7-9. Round 3: Refinement and Final Voting Statements near consensus were revised for clarity. Final voting achieved consensus on statements, forming the basis of the guidelines.

Conditions

Timeline

Start date
2025-12-25
Primary completion
2026-09-01
Completion
2026-12-01
First posted
2025-12-19
Last updated
2025-12-19

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07293793. Inclusion in this directory is not an endorsement.