PregnancyNCT07293793
Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
An observational study of Pregnancy and Skin Care, run by Venus Research Center at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Skin Care, Dermocosmetics
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: e study population consisted of a multidisciplinary panel of experts selected to represent diverse clinical, academic, and regional perspectives relevant to dermatologic care during pregnancy to ensure comprehensive evaluation of skin care ingredient safety, therapeutic practices, and procedure-related considerations for pregnant women.
Who may be able to join
- 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.
Who cannot join
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with Pregnant ladies.
- Industry representatives without direct clinical practice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Pregnancy, Skin Care, Dermocosmetics
- Keywords
- Consensus, Recommendations, Skin Care, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations
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.
Measured: 6-12 weeks
Secondary outcomes (1)
Classification of Dermatologic Ingredients and Procedures According to Safety Profile
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.
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293793
- Sponsor's protocol ID
- Pregnancy-Safe Skin Care-Venus
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
- ClinicalTrials.gov ID
- NCT07293793
- Acronym / sponsor ID
- Pregnancy-Safe Skin Care-Venus
- Conditions
- Pregnancy, Skin Care, Dermocosmetics
- Keywords
- Consensus, Recommendations, Skin Care, Pregnancy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Venus Research CenterUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- e study population consisted of a multidisciplinary panel of experts selected to represent diverse clinical, academic, and regional perspectives relevant to dermatologic care during pregnancy to ensure comprehensive evaluation of skin care ingredient safety, therapeutic practices, and procedure-related considerations for pregnant women.
Key inclusion criteria (5 listed)
- Board-certified dermatologist or plastic surgeon OR physician practicing aesthetic medicine.
Key exclusion criteria (3 listed)
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with Pregnant ladies.
- Industry representatives without direct clinical practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Classification of Dermatologic Ingredients and Procedures According to Safety Profile
Time frame: 6-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. Delphi studies do not collect patient data, medical records, biological samples, or identifiable clinical information. Experts only give opinions, not "IPD." Their responses are anonymized, and sharing identifiable expert-level responses is not required and often discouraged
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Skin Care, run by Venus Research Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations (time frame: 6-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.