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

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

Detailed Description
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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.

Official Title
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Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison With Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: Topical Herbal Solution
* Drug: Topical Minoxidil 5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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. | Drug: Topical Herbal Solution<br>* Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.<br>Drug: Topical Minoxidil 5%<br>* Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.<br>* Other names: Minoxidil;|
| Active Comparator: Control group<br>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. | Drug: Topical Minoxidil 5%<br>* Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.<br>* Other names: Minoxidil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hair Diameter | Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer. | baseline, 12, 24, and 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Self - Assessment Questionnaire | Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome. | through study completion | 
| Adverse Events | Incidence of adverse events such as itching, redness, inflammation etc | baseline, 12, 24, and 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgenic Alopecia, Hair Diseases, Skin Diseases, Baldness, Alopecia, Hair Loss