None listed
Conditions
Interventions
Intervention1: Minoxidil + Finasteride/Verisfield
cutaneous.spray solution. [50 mg/ml (5%) Minoxidil + 1 mg/ml (0.1%) Finasteride]: Spray 2 mL solution (morning and evening) for 24 weeks.
Control Int
Sponsors
Verisfield SMSA
Ms Ethicare Clinical Trial Services OPC Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male subjects with age between 18 to 41 years old (both inclusive). 2) Subjects must have a clear diagnosis of mild to moderate androgenetic alopecia (Stage II to V of the Norwood-Hamilton classification). 3) Subjects who have used Minoxidil 5% w/v topical solution in the past for at least 6 consecutive months but have responded insufficiently. 4) Subject who have willingness to maintain the same hairstyle, length and hair colour of the scalp throughout the study. 5) Subjects must be willing to provide written informed consent to participate in the study and comply with study procedures throughout study.
Exclusion criteria
Exclusion criteria: 1) Subjects who are undergoing hair growth or transplant treatment 3 months before screening into the study. 2) Subjects with following comorbidities, if clinically significant: - Concomitant scalp diseases with the possibility of interfering with the clinical study related evaluation methods such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy - Severe cardiovascular diseases - Renal diseases - Liver diseases - Neurological disease - Lung disease - Psychiatric disorder - History of hypersensitivity to any ingredients in the solution - clinical findings identified during the clinical examination or laboratory tests that somehow prevent participation in the study 3) Subjects who have received Finasteride in the last 6 months. 4) Subjects who are taking any other medicinal or supplement product that may affect hair growth except topical minoxidil. 5) Subjects with a history of alcohol or drug addiction. 6) Subjects with history of HIV, HBV and HCV. 7) Subjects who are on oral medications or suffering from chronic illness which will compromise the study. 8) Subjects who had treatment of cancer chemotherapy last 6 months before starting study or have a plan of treatment during the study term. 9) Subjects who have active hair loss or history within the past 3 months of hair loss other than androgenic alopecia, including diffuse telogen effluvium, alopecia areata, scarring alopecia. 10) Any severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results. 11) Subjects who have enrolled in any other investigational medication study currently, or within the last 30 days of screening. 12) Current use or history of use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or evaluations (including but not limited to Beta blockers, Cimetidine, Diazoxide, Isotretinoin, corticosteroids, Vitamin A intake above 10000 IU per day) within past 3 months. 13) Current use or history of use of local treatment (drug or cosmetically) on scalp interfering with the study product or evaluation (topical corticosteroids, hair growth formulation, medicated shampoos, topical estrogen, topical Ketoconazole) within past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hair density (by Trichoscopy)Timepoint: Baseline and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the hair diameter (by Trichoscopy)Timepoint: Baseline and week 24;Mean change in global photographic assessment score (GPAS)Timepoint: Baseline and week 24;Mean change in stages of scalp baldness (by Norwood-Hamilton classification)Timepoint: Baseline and week 24;Absolute and percentage change in dihydrotestosterone (DHT) levels.Timepoint: Baseline and week 24;Difference in number and frequency of adverse eventsTimepoint: Till week 24;Comparison of proportion of subjects having clinically significant change in laboratory parameters between test group vs reference group Timepoint: Baseline and week 24;Local tolerability assessmentTimepoint: At week 8, week 16 and week 24 | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.
Outcome results
None listed