CTRI/2024/05/067989
Recruiting
Phase 2
A Phase 2 randomized, double-blind, active- and placebo-controlled, parallel-group, multicenter trial to evaluate efficacy and safety of new topical formulations in the treatment of androgenetic alopecia in men
Glenmark Pharmaceuticals Ltd5 sites in 1 country236 target enrollmentStarted: June 10, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Glenmark Pharmaceuticals Ltd
- Enrollment
- 236
- Locations
- 5
- Primary Endpoint
- Change from baseline in non-vellus target area hair count (TAHC) at the end of treatment (Week 24)
Overview
Brief Summary
This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicentre study comparing the efficacy and safety of the topical Test formulations [Test formulation A (Dutasteride and Minoxidil 0.05%/5%); Test formulation B (Dutasteride and Latanoprost 0.05%/0.03% w/v); Minoxidil 5% Solution; Vehicle Solution] in the treatment of AGA in men. The study will be conducted at multiple sites in India. The anticipated maximum duration of study participation for each subject is up to 27 weeks. This consists of a screening period of up to 2 weeks, treatment period of up to 24 weeks and post-treatment 1-week follow-up. The primary outcome measure will be change from baseline in non-vellus TAHC at the end of treatment (Week 24). Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1.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.
- •Subject is willing to undergo study procedures for hair growth assessment including hair trimming and hair dye.
- •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.
- •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.
- •(Daily styling non-medicated products [e.g., hair oil, gel, styling spray, etc.] will be allowed on non-study visit days).
- •Subject is surgically sterile OR is willing to use a highly effective form of contraception.
Exclusion Criteria
- •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 study drug, examination or outcome, such as alopecia areata, other non-AGA forms of alopecia, fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
- •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 (e.g., uncontrolled thyroid disease, uncontrolled asthma, hypogonadism, human immunodeficiency virus [HIV] infection, connective tissue disease, inflammatory bowel disease, malignancy or suspicion of malignancy including prostate cancer, etc.).
- •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).
- •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 study drugs or put the subject at risk.
- •Subject has a current or recent history (within 3 months) of significant dietary changes or a history of eating disorder.
- •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.
Outcomes
Primary Outcomes
Change from baseline in non-vellus target area hair count (TAHC) at the end of treatment (Week 24)
Time Frame: From baseline to End of Treatment (Week 24)
Secondary Outcomes
- Change from baseline in non-vellus TAHC at Week 8 and 16(From Baseline to Week 8 and 16)
- Change from baseline in vellus TAHC at Week 8, 16, and 24.(From Baseline to Week 8, 16, and 24)
- Change from baseline in total TAHC at Week 8, 16, and 24.(From Baseline to Week 8, 16, and 24)
- Change from baseline in target area hair thickness (diameter) at Week 8, 16, and 24.(From Baseline to Week 8, 16, and 24)
- Proportion of subjects with more than and equal to +1 hair growth as assessed by Subject Self-Assessment (SSA) at Week 8, 16, and 24.(At Week 8, 16, and 24)
- Proportion of subjects with more than and equal to +1 hair growth as assessed by Investigator Global Assessment (IGA) at Week 8, 16, and 24.(At Week 8, 16, and 24.)
- Adverse events (from start to end of study)(From Start to End of study)
Investigators
Study Sites (5)
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