Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT07293793
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2025-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
Sponsor:
Venus Research Center
Organization:
Study Overview
Official Title:
Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: