Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

Launched by PIERRE FABRE DERMO COSMETIQUE · Aug 28, 2024

Keywords

ClinConnect Summary

4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Criteria related to the population:
• • - Subject aged between 18 and 60 years included
• Criteria related to the disease:
• Subject having a squamous state of the scalp :
• • clinically visible (Squire score ≥ 20),
• • with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
• • recurrent (at least twice a year)
• • associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)
• Exclusion Criteria:
• Criteria related to the diseases / skin condition:
• • Subject having frizzy hair
• • Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage\> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment
• Criteria related to treatments and/or products:
• • Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
• • Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
• • Any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion