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Comparison of intermittent and continuous regimens of oral dutasteride in the treatment of male androgenetic alopecia: A randomized, double-blind, dose-comparison randomized controlled trial

Comparison of intermittent and continuous regimens of oral dutasteride in the treatment of male androgenetic alopecia: A randomized, double-blind, dose-comparison randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260329002
Enrollment
72
Registered
2026-03-29
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male androgenetic alopecia male androgenetic alopecia male pattern hair loss dutasteride low-dose dutasteride intermittent regimens intermittent dosing

Interventions

oral dutasteride 0.5 mg 1 tab/day on Mon, Wed, Fri placebo 1 tab/day on Tue, Thur, Sat, Sun for 24 weeks,oral dutasteride 0.5 mg 1 tab/day on Mon-Fri placebo 1 tab/day on Sat, Sun for 24 weeks,oral du
oral dutasteride 0.5 mg 3 times/week,oral dutasteride 0.5 mg 5 times/week,oral dutasteride 0.5 mg once daily

Sponsors

Faculty of medicine, Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Androgenetic alopecia with mild to moderate severity

Exclusion criteria

Exclusion criteria: 1.History of kidney disease, liver disease, heart failure, or benign prostatic hyperplasia 2.History of breast cancer or prostate cancer, including previously treated cases 3.History of other medical conditions that may cause hair loss, such as anemia, hypo- or hyperthyroidism, systemic lupus erythematosus, malnutrition, and trichotillomania 4.History of treatment for hair loss using other modalities within 3 months prior to enrollment, such as low-level laser/light therapy (LLLT) or platelet-rich plasma (PRP) 5.History of other scalp dermatologic conditions such as psoriasis or tinea capitis 6.History of depression or suicidal ideation. Participants screened using the 2Q and 9Q depression screening tools with a score 7 or above will be excluded. 7.Individuals with psychiatric disorders, including trichotillomania, will also be excluded 8.History of allergy to 5 alpha reductase inhibitors or any inactive ingredients in the study medication. Family history of breast cancer or prostate cancer in first-degree relatives 9.9.History of using oral medications that may affect hair growth within 6 months prior to enrollment, including minoxidil, finasteride, dutasteride, flutamide, spironolactone, cyproterone acetate, cimetidine, diazoxide, cyclosporine, ketoconazole, anticonvulsants, and chemotherapeutic agents. Exception: prior use of dutasteride within 12 months before enrollment 10.History of using topical medications affecting hair growth within 3 months prior to enrollment, including minoxidil and finasteride 11.History of using hair growth promoting products within 1 month prior to enrollment, including ketoconazole shampoo

Design outcomes

Primary

MeasureTime frame
Change from baseline in hair density using videodermoscopy 24 weeks micrographs from videodermoscopy

Secondary

MeasureTime frame
Change from baseline in hair diameter using videodermoscopy 24 weeks micrographs from videodermoscopy,Overall clinical changes from baseline 24 weeks paired global photographs,patient satisfaction 24 weeks 10-point visual analog scale,adverse events 24 weeks interview, questionnaire,Change from baseline in serum DHT 24 weeks ELISA test for serum DHT,Change from baseline in serum PSA 24 weeks chemiluminescent immunoassay (CLIA) for serum PSA

Countries

Thailand

Contacts

Public ContactSaranya Khunkhet

Srinakharinwirot University

saranyakh@g.swu.ac.th0635691665

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026