The efficacy and safety of low-dose dutasteride versus finasteride in the treatment of male androgenetic alopecia

Phase 3

Completed

• Conditions: Male androgenetic alopecia (Hamilton-Norwood classification IIIvertex-V); Finasteride; Dutasteride; Male androgenetic alopecia; Low-dose dutasteride; Hair count; Hair density; Hair diameter; Videodermoscopy; Global photography

• Registration Number: TCTR20221106001
• Lead Sponsor: Faculty of Medicine, Srinakharinwirot University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-09-16
• Study Start: 2022-11-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

1. Male androgenetic alopecia
2. Age greater than or equal to 18 years old
3. Hamilton-Norwood classification (IIIvertex-V)
4. Able to follow-up
5. Willing to attend the project and sign informed consent form

Exclusion Criteria

1. Past history of renal disease, hepatic disease, heart failure, benign prostatic hyperplasia
2. Past history of breast cancer or prostate cancer
3. Family history of breast cancer or prostate cancer (1st-degree relatives)
4. Past history of depressive disorder or suicidal attempt or 2Q and 9Q screening for depression scores greater than or equal to 7
5. Allergic to 5-alpha-reductase inhibitors and inactive ingredients
6. History of topical medications which affecting hair growth within 3 months prior eg. minoxidil, topical finasteride
7. History of oral medications which affecting hair growth within 6 months prior ex. dutasteride (dose greater than 1.5 mg per week), finasteride, spironolactone, ketoconazole, cyclosporine, diazoxide, cimetidine, vasodilators, steroids, chemotherapeutic agents, and antiepileptic drugs
8. History of shampoos or scalp serums which affecting hair growth within 1 month prior eg. ketoconazole shampoo
9. History of taking medicines that can cause drug interactions with medicines in this study eg. rifampicin, carbamazepine, itraconazole
10. Past history of other hair loss treatments within 3 months prior ex. low-level laser/light therapy or platelet-rich plasma
11. Past history of hair transplant
12. Have underlying disease that cause hair loss eg. anemia, hypothyroid or hyperthyroidism, diabetes mellitus, chronic alcoholism, and maldigestion/malabsorption
13. Psychiatric disorder, including trichotillomania
14. Eating disorder or restricted diet
15. Other scalp disease ex. psoriasis, seborrheic dermatitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hair count at 6 months by Folliscope

Secondary Outcome Measures

Name	Time	Method
hair diameter at 6 months by Folliscope,hair density at 6 months by 7 point rating scale from global photography assessment,safety at 6 months questionnaire interview