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A randomized-sided, half-head study to evaluate the efficacy and safety of botulinum toxin A compared with platelet-rich plasma (PRP) in the treatment of male androgenetic alopecia

A randomized-sided, half-head study to evaluate the efficacy and safety of botulinum toxin A compared with platelet-rich plasma (PRP) in the treatment of male androgenetic alopecia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251220009
Enrollment
23
Registered
2025-12-20
Start date
2025-09-10
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 with the degree of scalp thinning classified by dermatologists as Hamilton-Norwood type III vertex to V, at the Dermatology Clinic, Siriraj Hospital efficacy, androgenetic alopecia, botulinum toxin A, platelet-rich plasma (PRP)

Interventions

Use Botulinum toxin A (brand MBTOX) at a concentration of 50 units per 2 mL (prepared by diluting 100 units of Botulinum toxin A in 4 mL of normal saline). A syringe connected to a 30-gauge needle is
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Botulinum toxin A injection,Platelet rich plasma injection

Sponsors

MNB Thai Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients who have been diagnosed with androgenetic alopecia, with the degree of scalp thinning classified by dermatologists as Hamilton-Norwood type III vertex to V, at the Dermatology Clinic, Siriraj Hospital, 2. Patients who have not received any prior treatment for androgenetic alopecia such as topical medications, oral medications, or injections for at least 6 months before enrolling in the study, 3. Patients whose lesions show equal severity on both sides of the scalp, 4. Patients who consent to participate in the research project and are able to attend follow-up visits throughout the study period

Exclusion criteria

Exclusion criteria: 1. Individuals with underlying medical conditions that contribute to hair loss, such as anemia, diabetes mellitus, hypo/hyperthyroidism, autoimmune diseases, malnutrition, telogen effluvium from various causes, and muscle weakness, 2. Individuals taking medications that contribute to hair loss, such as oral retinoids, antidepressants, and warfarin, 3. Patients with lesions or scalp infections in the treatment area during the period of study participation, whether untreated or previously treated, such as psoriasis, fungal infections of the scalp, and seborrheic dermatitis of the scalp 4.Patients with contraindications to PRP injection, such as those with bleeding tendencies or difficulty stopping bleeding, severe anemia, immunosuppressive therapy, coagulation disorders or use of anticoagulant medications, or bloodstream infections including HIV and hepatitis B or C, 5. Patients with thinning hair or baldness who have psychiatric disorders, such as trichotillomania diagnosed according to DSM-IV criteria, involving hair-pulling behavior resulting in patchy hair loss, 6. Individuals with a history of allergy to local anesthetics, 7. Patients who use additional oral or topical medications on their own that may affect hair growth, such as oral minoxidil and various vitamins

Design outcomes

Primary

MeasureTime frame
Hair density and hair shaft diameter compared on each side of the scalp Week 0, 12, 20 Trichoscan (FotoFinder medicam 1000) ,Hair density compared on each side of the scalp Week 0, 12, 20 7-point scale evaluated by patients and physicians

Secondary

MeasureTime frame
Side effects of Botulinum toxin A and PRP Week 0, 12, 20 Interview from patients

Countries

Thailand

Contacts

Public ContactPanchalee Mahaisavariya

Mahidol University

panchalee.mah@gmail.com0834949585

Outcome results

None listed

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