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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753113
• Other study ID #: TabrizUMS
• Status: Completed
• Phase: Phase 3
• Start date: November 28, 2018
• Est. completion date: September 2, 2019

Study information

• Verified date: March 2020
• Source: Tabriz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• Topical Herbal Solution
Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.
• Topical Minoxidil 5%
Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Dermatology, Sina Hospital	Tabriz	East Azerbaijan

Sponsors (1)

Lead Sponsor	Collaborator
Farid Masoud

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse Events	Incidence of adverse events such as itching, redness, inflammation etc	baseline, 12, 24, and 36 weeks