A randomized, non-inferiority trial of oral minoxidil 1.25 mg versus 5% topical minoxidil solution in the treatment of female pattern hair loss

Phase 2

Recruiting

• Conditions: Female pattern hair loss; oral minoxidil; topical minoxidil

• Registration Number: TCTR20201222005
• Lead Sponsor: Dermotology unit, King Chulalongkorn Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study Completion: 2022-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

1. Female patients, aged 18-65 year who were diagnosed with female pattern hair loss
2. History, clinical and dermoscope showed Savin scale I-4, II-1 and II-2
3. No treatment before or stop previous treatment at least 3 months prior to study

Exclusion Criteria

1. patients who have other co-morbidity diseases which effect to hair density such as any malignancy, anemia, hypothyroidism/hyperthyroidism, AIDS and autoimmune connective tissue disease and who have cardiovascular disease
2. patients who have other scalp disease ex. seborrheic dermatitis, scalp psoriasis, tinea capitis.
3. patients who have history of hair transplantation or have large scar on scalp
4. patients who have history of minoxidil allergy
5. pregnancy or lactation women
6. on Hormonal therapy or spironolactone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of terminal hair density at start, 12weeks, 24 weeks, 36 weeks and 48 weeks after start intervention Using Fotofinder Dermatoscope for evaluation of terminal hair density at midscalp

Secondary Outcome Measures

Name	Time	Method
Change of total hair density at start, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start intervention Using Fotofinder Dermatoscope for evaluation of total hair density at midscalp,Photographic assessment score at start, 24 weeks and 48 weeks after start intervention photographic assessment questionnaires,Satisfaction score at 24 weeks and 48 weeks after start intervention patient self-assessment questionnaires,Side effects at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start intervention questionnaires