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Enrolling by Invitation

NCT Number: NCT07293793

Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Venus Research Center

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Venus Research Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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