Clinical evaluation of the efficacy of a cosmetic product in reduction and prevention of stretch marks among participants with rapid weight fluctuations and pregnant women
Striae distensae including striae rubrae and striae albae
All participants will be receiving the same investigational product, Trofolastin Anti-Estrias Cream 178434. The investigational product will be applied twice daily on the mammae, axilla, abdomen, femur, gluteus and poplitea with a light massage until completely absorbed. Pregnant women will have four visits at the center over a duration of approximately 24 weeks. Participants with rapid weight fluctuations will have four visits at the center over a duration of 12 weeks and will have questionnaires to fill out at home on week 2 and week 6. The investigator will perform a cutaneous assessment of the participant’s skin on the mammae, axilla, abdomen, femur, gluteus and poplitea and will provide scoring based on the INA scale in each area studied on all four visits. Standardized photography, Chromameter®, Corneometer®, Cutometer®, and Tewameter® measurements will be done on a selected stretch mark at each visit at the centre. Participants will also complete subjective evaluation questionnaires.
Either: 1. Pregnant woman aged of at least 18 years old and at ≤20 weeks of gestation (Group 1), or 2. Male/female participant aged above 12 years old with rapid weight fluctuations (Group 2). Weight loss of more than 5% of usual body weight over 6–12 months is considered significant 3. Participant of phototype I-VI (according to Fitzpatrick scale) 4. Participant presenting with new and/or existing striae distensae (striae rubrae/striae alba due to: 4.1. Pregnancy (primiparous/multiparous women) or 4.2. Rapid weight fluctuations 5. 30% of participants with sensitive skin (declarative) 6. Participant accepting the constraints of the study protocol 7. Participant who has signed their informed consent for their participation in the study 8. Participant able to understand the language used in the investigational center and the information given
1. Participant presenting with new and/or existing striae distensae due to systemic diseases such as Cushing’s syndrome or high dose of corticosteroid intake 2. Participant considered by the investigator to be likely to be non-compliant with the protocol 3. Participant having dermatological disorders other than striae distensae affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems) 4. Participant having history of skin cancer 5. Participant using another treatment for stretch marks during the study period or within two weeks prior to inclusion. 6. Participant having allergy, hypersensitivity, or any serious reaction to any cosmetic product 7. Participant having any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator 8. Participant having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics, e.g., quinolone, tetracycline, thiazides, fluoroquinolones) 9. Participant within the rapid weight fluctuations group (Group 2) who is breastfeeding, pregnant or considering a pregnancy during the study 10. Participant currently participating in another clinical study. 11. Participant who has been deprived of liberty by adjunction or by official decision. 12. Participant who cannot be contacted by telephone in case of emergency 13. Intellectual/mental inability to follow study instructions (if suspected) or incapacitation 14. Participants working for the contract research organization in charge of this study