A randomized, non-inferiority trial of the serum containing three herbal mixtures versus 5% topical minoxidil solution in the treatment of early stage of male androgenetic alopecia and female pattern hair loss

Phase 3

Recruiting

• Conditions: Male and female patients diagnosed with androgenic alopecia; three herbal mixtures hair serum, hair thining, androgenic alopecia, minoxidil

• Registration Number: TCTR20240810005
• Lead Sponsor: Chanat Kumtornrut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-10
• Last Update Posted: 19 August 2024
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Male and female patients diagnosed with androgenic alopecia.
2. Aged 18-65 years.
3. The stages of androgenic alopecia in males, according to the revised Hamilton's classification, are at levels II, III, III vertex, or IV. The stages of androgenic alopecia in females, according to the Savin scale, are at levels I-2, I-3, I-4, or II-1.

Exclusion Criteria

1. Participants with other hair or scalp diseases, such as seborrheic dermatitis, scalp psoriasis, scalp fungal infections, telogen effluvium, or scarring alopecia.
2. Participants with medical conditions or chronic illnesses that cause hair loss, such as cancer, anemia, thyroid hormone abnormalities, immunodeficiency, or connective tissue diseases.
3. Participants who have undergone hair transplant surgery.
4. Participants who need to use androgen hormones or anti-androgen medications, such as spironolactone, or use hormonal medications for contraception or hormone regulation.
5. Participants who are pregnant or breastfeeding.
6. Participants with a history of allergy to minoxidil or any other components in the topical minoxidil solution.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hair density baseline, week6, week 12, week 24 by fotofinder dermoscope (Total hair counts, teminal hair counts, vellus hair counts))

Secondary Outcome Measures

Name	Time	Method
global photographic evaluation baseline, week6, week 12, week 24 the standardized 7-point rating score using scalp photographs from -3; significant disease progression to +3; significant improvement.,hair growth questionnaire baseline, week6, week 12, week 24 growth of hair, amount of noticeable new hair, visibility of the scalp, rate of hair loss