Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
NCT ID: NCT07293793
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
15 participants
OBSERVATIONAL
2025-12-25
2026-12-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Expert Panel
A cohort of dermatology and aesthetic medicine experts from the MENA region participating in a Modified Delphi process to develop consensus recommendations on Skin Care dermo cosmetics in Pregnancy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Minimum of 5 years of clinical experience.
* Practicing within Egypt or the Middle East and North Africa (MENA) region.
* Willingness to participate in Delphi rounds and provide expert ratings.
* Ability to read and respond to surveys in English.
Exclusion Criteria
* Lack of clinical experience with Pregnant ladies.
* Industry representatives without direct clinical practice.
25 Years
ALL
Yes
Sponsors
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Venus Research Center
OTHER
Responsible Party
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Locations
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Venus Research Center
Cairo, , Egypt
Countries
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Other Identifiers
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Pregnancy-Safe Skin Care-Venus
Identifier Type: -
Identifier Source: org_study_id