Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT07293793
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2025-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2025-12-06', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of Expert Consensus on Pregnancy-Safe Skin Care Recommendations', 'timeFrame': '6-12 weeks', 'description': '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:\n\n≥75% of experts scoring a statement 7-9 on a 9-point Likert scale (agreement),\n\nwith a median score ≥7.\n\nThis outcome reflects the degree to which experts converged on the safety categories, usage guidelines, and clinical management strategies for skin care in pregnant patients.'}], 'secondaryOutcomes': [{'measure': 'Classification of Dermatologic Ingredients and Procedures According to Safety Profile', 'timeFrame': '6-12 weeks', 'description': 'A key secondary outcome was the categorization of commonly used dermatologic and cosmetic components into:\n\nSafe\n\nUse with Caution (insufficient or limited evidence)\n\nAvoid (potential teratogenic risk or high systemic absorption)\n\nThis includes topical ingredients, professional procedures, and over-the-counter skin care actives.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Consensus', 'Recommendations', 'Skin Care', 'Pregnancy'], 'conditions': ['Pregnancy', 'Skin Care', 'Dermocosmetics']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background and Rationale\n\nPregnancy 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.\n\nDespite 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.\n\nMethods: Delphi Consensus Process\n\nA structured three-round Delphi methodology was used to achieve consensus among a multidisciplinary panel of dermatologists, obstetricians, and pharmacology experts.\n\n2.1. Panel Composition\n\nN = 25 experts\n\nRepresentatives from dermatology, maternal-fetal medicine, and clinical pharmacology\n\nMinimum of 5 years of clinical experience\n\nGeographic representation from MENA, Europe, and Asia\n\nSteps in the Delphi Process Round 1: Exploration\n\nExperts provided open-ended responses on:\n\nEssential principles of pregnancy-safe skin care\n\nIngredient safety classifications\n\nPreferred management of common dermatologic conditions\n\nCultural and regional care considerations\n\nA qualitative analysis was performed to derive core themes.\n\nRound 2: Structured Statements\n\n75 draft statements were generated and rated using a 9-point Likert scale\n\n1-3: Disagree\n\n4-6: Uncertain\n\n7-9: Agree\n\nConsensus defined as ≥ 75% of experts rating 7-9.\n\nRound 3: Refinement and Final Voting\n\nStatements near consensus were revised for clarity.\n\nFinal voting achieved consensus on statements, forming the basis of the guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Board-certified dermatologist or plastic surgeon OR physician practicing aesthetic medicine.\n\n * Minimum of 5 years of clinical experience.\n * Practicing within Egypt or the Middle East and North Africa (MENA) region.\n * Willingness to participate in Delphi rounds and provide expert ratings.\n * Ability to read and respond to surveys in English.\n\nExclusion Criteria:\n\nInability or unwillingness to complete Delphi rounds.\n\n* Lack of clinical experience with Pregnant ladies.\n* Industry representatives without direct clinical practice.'}, 'identificationModule': {'nctId': 'NCT07293793', 'briefTitle': 'Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations', 'organization': {'class': 'OTHER', 'fullName': 'Venus Research Center'}, 'officialTitle': 'Pregnancy-Safe Skin Care Guidelines: Expert Consensus Recommendations', 'orgStudyIdInfo': {'id': 'Pregnancy-Safe Skin Care-Venus'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Expert Panel', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Venus Research Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venus Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}