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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753113
Recruitment Status : Completed
First Posted : November 26, 2018
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
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 Drug: Topical Herbal Solution Drug: Topical Minoxidil 5% Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

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 Name: 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 Name: Minoxidil




Primary Outcome Measures :
  1. Change in Hair Diameter [ Time Frame: baseline, 12, 24, and 36 weeks ]
    Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.


Secondary Outcome Measures :
  1. Patients Self - Assessment Questionnaire [ Time Frame: through study completion ]
    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.

  2. Adverse Events [ Time Frame: baseline, 12, 24, and 36 weeks ]
    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 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

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


Locations
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Iran, Islamic Republic of
Department of Dermatology, Sina Hospital
Tabriz, East Azerbaijan, Iran, Islamic Republic of
Sponsors and Collaborators
Farid Masoud
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Farid Masoud, Tabriz University of Medical Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Farid Masoud, Principal Investigator, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03753113    
Other Study ID Numbers: TabrizUMS
First Posted: November 26, 2018    Key Record Dates
Results First Posted: March 16, 2020
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents