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Efficacy and Safety Study to Compare Topical Herbal Solution and Minoxidil 5% in Male Pattern Hair Loss

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ClinicalTrials.gov Identifier: NCT03753113
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Farid Masoud, Tabriz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Other: Topical Herbal Solution Drug: Topical Minoxidil 5% Phase 3

Detailed Description:

This study will be done on male subjects with androgenetic alopecia. 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 12 to 24 weeks.

This herbal solution for the first time covers all three major causes of androgenetic alopecia, namely the 5α-reductase enzyme, androgen receptors, and paracrine agents that affecting dermal papilla.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Clinical Trial of the Efficacy and Safety Study to Compare Topical Herbal Solution and Minoxidil 5% in Healthy Male Subjects With Androgenetic Alopecia
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Experimental: Treatment group
apply on the scalp 1ml of the Topical Herbal Solution plus Topical Minoxidil 5%
Other: Topical Herbal Solution
Use Topical Herbal Solution every day in scalp hair loss areas for 3-6 months

Drug: Topical Minoxidil 5%
Use Minoxidil 5% solution every day in scalp hair loss areas for 3-6 months
Other Name: Minoxidil

Active Comparator: Control group
apply on the scalp 1ml of the Topical Minoxidil 5%
Drug: Topical Minoxidil 5%
Use Minoxidil 5% solution every day in scalp hair loss areas for 3-6 months
Other Name: Minoxidil




Primary Outcome Measures :
  1. Change in mean total hair density [ Time Frame: baseline, 2 months later, 4 or 6 months later ]
    Change in hair density over time as compared to Baseline. Hair density will be measured using macrophotography.

  2. Change in hair diameter [ Time Frame: baseline, 2 months later, 4 or 6 months later ]
    Change in hair diameter over time as compared to Baseline. Measure hair diameter using electronic outside micrometre.


Secondary Outcome Measures :
  1. Change in hair growth as assessed by the investigator [ Time Frame: baseline, 2 months later, 4 or 6 months later ]
    Change in investigator global photograph rating from baseline

  2. Subject Satisfaction Questionnaire [ Time Frame: baseline, 2 months later, 4 or 6 months later ]
    self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and 3 questions on satisfaction with appearance

  3. Adverse Events [ Time Frame: baseline, 2 months later, 4 or 6 months later ]
    Incidence of adverse events such as itching, redness, inflammation etc



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy men 18 to 50 years old
Accepts Healthy Volunteers:   Yes
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 3 months
  • Within 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753113


Contacts
Contact: Farid Masoud, PharmD +98 9036859062 faridmasoud@gmail.com

Locations
Iran, Islamic Republic of
Department of Dermatology, Sina Hospital Recruiting
Tabriz, East Azerbaijan, Iran, Islamic Republic of
Contact: Hamideh Azimi Alamdari, MD    +98 41 3541 2151    hamide_azimi@yahoo.com   
Principal Investigator: Farid Masoud, PharmD         
Sponsors and Collaborators
Farid Masoud
Investigators
Principal Investigator: Farid Masoud, PharmD Pharmacy Faculty
Study Director: Yousef Javadzadeh, Ph.D Pharmaceutics Department, Pharmacy Faculty
Study Director: Javad Shokri, Ph.D Pharmaceutics Department, Pharmacy Faculty

Responsible Party: Farid Masoud, Principal Investigator, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03753113     History of Changes
Other Study ID Numbers: TabrizUMS
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Farid Masoud, Tabriz University of Medical Sciences:
Androgenic Alopecia
Hair Diseases
Skin Diseases
Baldness
Alopecia
Hair Loss

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Minoxidil
Antihypertensive Agents
Vasodilator Agents