- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293793
Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Venus Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Board-certified dermatologist or plastic surgeon OR physician practicing aesthetic medicine.
- 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:
Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with Pregnant ladies.
- Industry representatives without direct clinical practice.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations
Time Frame: 6-12 weeks
|
The primary outcome of this Delphi study was to establish consensus-based, evidence-aligned recommendations for safe skin care practices, cosmetic ingredients, and dermatologic treatments during pregnancy. Consensus was defined a priori as: ≥75% of experts scoring a statement 7-9 on a 9-point Likert scale (agreement), with a median score ≥7. This outcome reflects the degree to which experts converged on the safety categories, usage guidelines, and clinical management strategies for skin care in pregnant patients. |
6-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Classification of Dermatologic Ingredients and Procedures According to Safety Profile
Time Frame: 6-12 weeks
|
A key secondary outcome was the categorization of commonly used dermatologic and cosmetic components into: Safe Use with Caution (insufficient or limited evidence) Avoid (potential teratogenic risk or high systemic absorption) This includes topical ingredients, professional procedures, and over-the-counter skin care actives. |
6-12 weeks
|
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
Keywords
Other Study ID Numbers
- Pregnancy-Safe Skin Care-Venus
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.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Kafrelsheikh UniversityNot yet recruitingEctopic PregnancyEgypt
-
Meir Medical CenterRecruiting
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Bagcilar Training and Research HospitalRecruitingEctopic PregnancyTurkey (Türkiye)
-
MELISA Institute Genomics & Proteomics Research...RecruitingHealthy | Pregnancy | Early Pregnancy | Early Pregnancy Loss | ChildbirthChile
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
Hopital Antoine BeclereUnknown