Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Fixed Dose Combination (FDC) of Minoxidil 5.00 % w/v, Finasteride 0.10 % w/v and Latanoprost 0.03 % w/v
: Subjects will be applying 5 sprays(1 ml) Topical FDC Solution (Minoxidil 5.00
Sponsors
Pure and Cure Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males aged between 18-49 years 2. Balding stage of III Vertex to V on the Norwood-Hamilton scale 3. Willingness to participate and signing the informed consent form 4. Subjects willing to maintain the same hair style and color through-out the study. 5. Subjects willing to clip hair in target area at the anterior leading edge of the vertex balding scalp, centered by a small dot.
Exclusion criteria
Exclusion criteria: 1. Balding stage of IIA to VA on the Norwood-Hamilton scale 2. Subjects with known hypersensitivity to Minoxidil or Adenosine or any of the ingredients of the test drugs or tattoo ink. 3. Any dermatological disorders of the scalp 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. 4. Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia. 5. Any severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results. 6. Subjects who had hair transplant surgery, hair weaves or non-breathable wigs and hair bonding. 7. Use of any anti-hair loss treatment within the last 6 months prior to the screening visit including Minoxidil, Finasteride, Dutasteride or similar products. 8. 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 (Beta blockers, Cimetidine, Diazoxid, Isotretinoin, corticosteroids, Vitamin A intake above 10000 IU per day) within past 3 months. 9. Current use or history of use of local treatment (drug or cosmetically) on scalp interfering with the study product or evaluation (topical corticosteroids, Aminexil, Minoxidil, medicated shampoos, topical estrogen, topical Ketoconazole) within past 4 weeks. 10. Enrolled in any other investigational medication study currently, or within the last 6 months 11. History of undergoing chemotherapy or receiving cytotoxic agents or radiation and/or laser/surgical therapy of the scalp within past 6 months. 12. Subjects with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed the threshold limits set out for this study, the approval of Medical Monitor should be taken into consideration before randomizing the subject). 13. Subjects with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculate the Odds Ratio for responders achieving superior hair count (nonvellus hair) and/or increased hair diameter per cm , as measured by trichometry, in the test group compared to reference productsTimepoint: From baseline or randomization to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Calculate mean hair count increase of non-vellus hair per square cm measured from baseline or randomization to Week 24 by trichometry in the test group compared to reference productsTimepoint: From baseline or randomization to Week 24;Calculate mean hair diameter increase of non-vellus hair per square cm assessed from baseline or randomization to Week 24 by trichometry in the test group compared to reference products.Timepoint: From baseline or randomization to Week 24 | — |
Countries
India
Contacts
Public ContactMr Umakant Ghodke
Pure and Cure Healthcare Pvt Ltd
Outcome results
None listed