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Enrolling by invitation NCT07293793

Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations

Observational Pregnancy Skin Care Dermocosmetics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnancy, Skin Care, Dermocosmetics. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations [Time frame: 6-12 weeks]
Secondary outcome measures (1)
  • Classification of Dermatologic Ingredients and Procedures According to Safety Profile [Time frame: 6-12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • Venus Research Center — Cairo

Identifiers

NCT: NCT07293793 · Pregnancy-Safe Skin Care-Venus

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗