Striae distensae including striae rubrae and striae albae Skin and Connective Tissue Diseases
Conditions
Interventions
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, fem
Sponsors
Stada Arzneimittel (Germany)
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of striae distensae measured using clinical grading of striae distensae by investigator based on the INA scale. The assessment will include the evaluation of overall severity over time based on a standardized scoring system. Assessment will be done intra participant, comparing to each participant’s baseline. Prevention will be assessed through occurrence/progression of new striae and worsening of existing ones. Measured at the baseline visit, at 25th or 26th week of pregnancy, at 33rd or 34th week of pregnancy, and end of study visit after delivery for pregnant women; and at D0, week 4, week 8 and week 12 for rapid weight fluctuations participants;Skin color measured using Chromameter® at the baseline visit, at 25th or 26th week of pregnancy, at 33rd or 34th week of pregnancy, and end of study visit after delivery for pregnant women; and at D0, week 4, week 8 and week 12 for rapid weight fluctuations participants;Skin hydration measured using Corneometer® at the baseline visit, at 25th or 26th week of pregnancy, at 33rd or 34th week of pregnancy, and end of study visit after delivery for pregnant women; and at D0, week 4, week 8 and week 12 for rapid weight fluctuations participants;Skin elasticity/firmness measured using Cutometer® at the baseline visit, at 25th or 26th week of pregnancy, at 33rd or 34th week of pregnancy, and end of study visit after delivery for pregnant women; and at D0, week 4, week 8 and week 12 for rapid weight fluctuations participants;Skin barrier status measured using Tewameter® at the baseline visit, at 25th or 26th week of pregnancy, at 33rd or 34th week of pregnancy, and end of study visit after delivery for pregnant women; and at D0, week 4, week 8 and week 12 for rapid weight fluctuations participants | — |
Countries
Mauritius
Contacts
Public ContactAshwina Seetaloo
Outcome results
None listed