An observational study to assess clinical impact of hair serum in Indian Patients with patterned hair loss
- Conditions
- Androgenic alopecia, unspecified,
- Registration Number
- CTRI/2023/07/055158
- Lead Sponsor
- Not applicable
- Brief Summary
This is a Multicenter, Case-cohort, Observational study planned to assess Safety & Clinical impact of Curcumin longa based Hair Serum in Indian Patients with hair loss.
Cuticapil serum is a combination of biotinyl GHK with apigenin a flavonoid from citrus and oleanolic acid from olive tree leaves. Also liposome based Caffeine and Cressantine works on unique mechanism to improve hair growth. It is also enriched with Biotin Plus.
The rationale of this study is to assess real world clinical safety and efficacy of Cuticapil Stem hair serum in patterned hair loss in men & women in India.
As the study will be conducted in the real life setting, study medication will be prescribed by the investigator and the patients will purchase the drug from the pharmacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 120
- Male or female patients of 18 or above with diagnosis of hair loss Hair shedding > 6 month Clinical diagnosis of male AGA Grade III, Grade IV, Grade V and clinical diagnosis of FPHL Grade II and Grade III naïve cases or treated with 5% Minoxidil.
- Patients with no known allergy.
- Patients who agree to refrain from using hair dye, oil treatment or spa treatment, perming or straightening during the treatment/observation period Patients who agree to use Non ketoconazole based shampoo.
Cosmetic hair treatments 1 month prior to enrolment Patients with Hemoglobin level below 10.5 Patients with thyroid disorders or other systemic disorders including T2DM, Hypertension, HIV, Hepatitis, Anemia, Heart disorders, Cancer & undergone chemotherapy, Depression, any psychiatric disorders and those taking drugs which could cause alopecia Pregnant and lactating females Patients with scalp disease Heavy Smokers & heavy drinkers Patients on crash diets.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in hair count shedding after shampooing from baseline at 10 weeks. at 10 week Change in hair count with Pull test from baseline at 10 weeks. at 10 week Global photography assessment at 10 week as centrally adjudicated scale score at 10 week for hair count. at 10 week
- Secondary Outcome Measures
Name Time Method Safety assessment of the hair serum AGA, FPHL, Patient Global Assessment
Trial Locations
- Locations (9)
Asia Institute of Hair Transplant
🇮🇳Pune, MAHARASHTRA, India
DERMALIFE REDEFINE YOURSELF
🇮🇳West, DELHI, India
Dr Ganjoos Skin & Cosmetology Centre
🇮🇳West, DELHI, India
Dr Manjul Agrwals Clinic
🇮🇳West, DELHI, India
Dr Shreyas Kamath - Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Dr Vaidyas Skin & Laser Clinic
🇮🇳Pune, MAHARASHTRA, India
GNH Excel Medical Centre
🇮🇳West, DELHI, India
RD Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Rejoice Aesthetic Experts
🇮🇳Mumbai, MAHARASHTRA, India
Asia Institute of Hair Transplant🇮🇳Pune, MAHARASHTRA, IndiaDr Pradeep KumariPrincipal investigator9623050666Drpkumari263@gmail.com