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

NCT03753113 | Completed Phase 3 Results

• 1 other identifier: TabrizUMS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

Androgenic Alopecia; Hair Diseases; Skin Diseases; Baldness; Alopecia; Hair Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patients Self - Assessment Questionnaire

  through study completion

• Adverse Events

  baseline, 12, 24, and 36 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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; Drug: Topical Minoxidil 5%

Control group

ACTIVE COMPARATOR

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%

Interventions

Topical Herbal Solution DRUG

Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.

Treatment group

Topical Minoxidil 5% DRUG

Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.

Also known as: Minoxidil

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Healthy men 18 to 50 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Farid Masoud: lead

Study Sites (1)

Department of Dermatology, Sina Hospital

Tabriz, East Azerbaijan Province, Iran

Location

Related Publications (1)

• 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.

  PMID: 33112463 DERIVED

MeSH Terms

Conditions

Alopecia; Hair Diseases; Skin Diseases

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Small numbers of subjects

Results Point of Contact

• Title: Dr. Farid Masoud
• Organization: Tabriz University of Medical Sciences

faridmasoud@gmail.com

+989036859062

Study Officials

• Farid Masoud, PharmD

  Pharmacy Faculty

  PRINCIPAL INVESTIGATOR

• Yousef Javadzadeh, Ph.D

  Department of Pharmaceutics, Pharmacy Faculty

  STUDY DIRECTOR

• Hamideh Azimi Alamdari, MD

  Department of Dermatology, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Solmaz Asnaashari, Ph.D

  Department of Pharmacognosy, Pharmacy Faculty

  STUDY DIRECTOR

• Javad Shokri, Ph.D

  Department of Pharmaceutics, Pharmacy Faculty

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 26, 2018
• Study Start: November 28, 2018
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)