An observational study to assess clinical impact of hair serum in Indian Patients with patterned hair loss
- Conditions
- Health Condition 1: L649- Androgenic alopecia, unspecified
- Registration Number
- CTRI/2023/07/055158
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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. <br/ ><br> <br/ ><br> <br/ ><br>Change in hair count with Pull test from baseline at 10 weeks. <br/ ><br> <br/ ><br>Global photography assessment at 10 week as centrally adjudicated scale score <br/ ><br>for hair count.Timepoint: at 10 week
- Secondary Outcome Measures
Name Time Method Safety assessment of the hair serum <br/ ><br>AGA, FPHL, Patient Global Assessment <br/ ><br>Timepoint: At 10 week