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

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

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

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: Topical Herbal Solution; Drug: Topical Minoxidil 5%

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • East Azerbaijan
    • Tabriz, East Azerbaijan, Iran, Islamic Republic of
      • Department of Dermatology, Sina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Farid Masoud
• Investigators: Principal Investigator: Farid Masoud, PharmD, Pharmacy Faculty; Study Director: Yousef Javadzadeh, Ph.D, Department of Pharmaceutics, Pharmacy Faculty; Principal Investigator: Hamideh Azimi Alamdari, MD, Department of Dermatology, Faculty of Medicine; Study Director: Solmaz Asnaashari, Ph.D, Department of Pharmacognosy, Pharmacy Faculty; Study Director: Javad Shokri, Ph.D, Department of Pharmaceutics, Pharmacy Faculty

Publications and helpful links

General Publications

• Masoud F, Alamdari HA, Asnaashari S, Shokri J, Javadzadeh Y. Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study. Dermatol Ther. 2020 Nov;33(6):e14467. doi: 10.1111/dth.14467. Epub 2020 Nov 5.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): September 2, 2019

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Baldness; Alopecia; Hair Loss; Skin Diseases; Hair Diseases; Androgenic Alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: TabrizUMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No