Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Treatment 1 (Clascoterone and Minoxidil Topical Solution): Dosage Form: Solution for topical application
Dose: 1 g
Dosage Frequency: Twice daily
Mode of Administration: Local topical
Sponsors
Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is willing to provide written informed consent. 2. Male subject of 20 to 55 (both inclusive) years of age with a clinical diagnosis of AGA and Norwood-Hamilton pattern of baldness III vertex, IV or V. 3. Subject is willing to undergo study procedures for hair growth assessment including hair trimming and hair dye. 4. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study and only use suggested hair shampoo, conditioner, and hair style products during the study. 5. Subject is agreeing to refrain from hair weaving, new hair colorants or dyes and non- study hair growth products (topical or systemic) or devices during the study. 6. Subject is surgically sterile OR is willing to use a highly effective form of contraception.
Exclusion criteria
Exclusion criteria: 1. Subject has current or recent history (within 3 months) of any dermatological disorders of the scalp other than AGA which, in the Investigator s opinion, may interfere with the application of the investigational product, examination or outcome, such as other non- AGA forms of alopecia, fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, significant sunburn to the scalp, scars, or scalp atrophy. 2. Subject has current or history of clinical diagnosis of alopecia areata, scalp scars and atrophy. 3. Subject has history of any medical condition which, in the opinion of the Investigator, could influence the hair growth, interfere with the evaluation of the study treatment for safety and efficacy or requires the use of interfering topical or systemic therapy. 4. Subject has known hypersensitivity, previous allergic reaction or contraindication to any of the active or inactive component(s) of the study treatment or the products used in procedures (e.g., hair dye). 5. Subject with clinically significant finding(s) from medical history including suspicion of infertility, physical examination, laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the evaluation of the investigational products or put the subject at risk. 6. Subject has a current or recent history (within 3 months) of significant dietary changes or a history of eating disorder. 7. Subject with history of platelet rich plasma (PRP) procedure on the scalp within 6 months of randomization. 8. Subject with history of hair transplants, hair weaves or non-breathable wigs. 9. Current use or history of using any of the prohibited topical or systemic treatment(s) or procedure(s) on the scalp which, in the opinion of the Investigator, could influence the hair growth and interfere with the evaluation of the study treatment. 10. Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals. 11. Subject with history of substance/drugs/alcohol abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject s participation in the study. 12. Subject with history of HIV, hepatitis B, and hepatitis C infection. 13. Subject is not agreeing to restrain from blood donation during the study. 14. Subject with history of investigational drug/device use or participation in an interventional trial within 3 months or 5 half-lives of the product (whichever is longer) prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in non-vellus target area hair count (TAHC) at the end of treatment (Week 24)Timepoint: At Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (Week 0 to end of study).Timepoint: Throughout the study period;Change from baseline in non-vellus TAHC at Week 8 & 16.Timepoint: At Week 8 & 16;Change from baseline in vellus TAHC at Week 8, 16, & 24.Timepoint: At Week 8, 16 & 24;Change from baseline in total TAHC at Week 8, 16, & 24.Timepoint: At Week 8, 16 & 24;Change from baseline in target area hair thickness (diameter) at Week 8, 16, & 24.Timepoint: At Week 8, 16 & 24;Proportion of subjects with more than & equal to +1 rating of hair growth as assessed by Subject Self-Assessment (SSA) at Week 8, 16, & 24.Timepoint: At Week 8, 16 & 24;Proportion of subjects with more than & equal to +1 rating of hair growth as assessed by Investigator Global Assessment (IGA) at Week 8, 16, & 24.Timepoint: At Week 8, 16 & 24 | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Limited
Outcome results
None listed