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

NCT ID: NCT03753113

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2019-09-02

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.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Topical Herbal Solution

Intervention Type: DRUG

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

Topical Minoxidil 5%

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Topical Minoxidil 5%

Intervention Type: DRUG

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

Interventions

Topical Herbal Solution

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

Intervention Type: DRUG

Topical Minoxidil 5%

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

Intervention Type: DRUG

Other Intervention Names

Minoxidil

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Farid Masoud

OTHER

Sponsor Role: lead

Responsible Party

Farid Masoud

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Farid Masoud, PharmD

Role: PRINCIPAL_INVESTIGATOR

Pharmacy Faculty

Yousef Javadzadeh, Ph.D

Role: STUDY_DIRECTOR

Department of Pharmaceutics, Pharmacy Faculty

Hamideh Azimi Alamdari, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Faculty of Medicine

Solmaz Asnaashari, Ph.D

Role: STUDY_DIRECTOR

Department of Pharmacognosy, Pharmacy Faculty

Javad Shokri, Ph.D

Role: STUDY_DIRECTOR

Department of Pharmaceutics, Pharmacy Faculty

Locations

Department of Dermatology, Sina Hospital

Tabriz, East Azerbaijan Province, Iran

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 33112463 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

TabrizUMS

Identifier Type: -

Identifier Source: org_study_id