Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%

Farid Masoud

Status and phase: Completed; Phase 3

Conditions: Androgenetic Alopecia

Treatments: Drug: Topical Herbal Solution; Drug: Topical Minoxidil 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT03753113

TabrizUMS

Details and patient eligibility

About

The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.

Full description

This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible individuals will be selected among them. Subjects were randomized to use either Topical Herbal Solution or Topical Minoxidil 5% for 36 weeks.

To our knowledge, this herbal solution for the first time covers all four major causes of AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple mechanism. The application of this new herbal solution for the treatment of AGA should be recommended.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men 18 to 50 years old
• Written consent
• Normal general health status
• Men who have a presentation of androgenetic alopecia (Norwood II - V).

Exclusion criteria

• Use of any topical product in the target region interfering with the study product in the last three months
• Within the past 6 months receiving of chemotherapy/cytotoxic agents
• Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
• Uncontrolled hypertension
• Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer
• Hormonal diseases such as thyroid disorders, diabetes and, ...
• Smokers
• Liver and kidney disease
• History of hair transplants
• History of surgical correction of hair loss on the scalp
• Subject having dyed, bleached hair or, with a permanent wave prior to study start.
• No written consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Treatment group

Experimental group

Description:

The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.

Treatment:

Drug: Topical Minoxidil 5%

Drug: Topical Herbal Solution

Control group

Active Comparator group

Description:

The patients will be applied 1 mL of Minoxidil 5% solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.

Treatment:

Drug: Topical Minoxidil 5%