Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
- Conditions
- Androgenetic Alopecia
- Interventions
- Drug: Topical Herbal Solution
- Registration Number
- NCT03753113
- Lead Sponsor
- Farid Masoud
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
- Men 18 to 50 years old
- Written consent
- Normal general health status
- Men who have a presentation of androgenetic alopecia (Norwood II - V).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Topical Herbal Solution 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. Control group Topical Minoxidil 5% 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 group Topical Minoxidil 5% 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.
- Primary Outcome Measures
Name Time Method Change in Hair Diameter baseline, 12, 24, and 36 weeks Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.
- Secondary Outcome Measures
Name Time Method Patients Self - Assessment Questionnaire through study completion 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.
Adverse Events baseline, 12, 24, and 36 weeks Incidence of adverse events such as itching, redness, inflammation etc
Trial Locations
- Locations (1)
Department of Dermatology, Sina Hospital
🇮🇷Tabriz, East Azerbaijan, Iran, Islamic Republic of