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临床试验/NCT07293793
NCT07293793Enrolling By Invitation不适用

Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations

Venus Research Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
15
试验地点
1
主要终点
Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Inability or unwillingness to complete Delphi rounds.
  • Lack of clinical experience with Pregnant ladies.
  • Industry representatives without direct clinical practice.

结局指标

主要结局

Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations

时间窗: 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.

次要结局

  • Classification of Dermatologic Ingredients and Procedures According to Safety Profile(6-12 weeks)

研究者

发起方
Venus Research Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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