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

Primary Purpose

Androgenetic Alopecia

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Topical Herbal Solution

Topical Minoxidil 5%

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenic Alopecia, Hair Diseases, Skin Diseases, Baldness, Alopecia, Hair Loss

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Department of Dermatology, Sina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Hair Diameter

Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.

Secondary Outcome Measures

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.

Adverse Events

Incidence of adverse events such as itching, redness, inflammation etc

Full Information

NCT ID

NCT03753113

First Posted

November 21, 2018

Last Updated

March 1, 2020

Sponsor

Farid Masoud

1. Study Identification

Unique Protocol Identification Number

NCT03753113

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

November 28, 2018 (Actual)

Primary Completion Date

September 2, 2019 (Actual)

Study Completion Date

September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Farid Masoud

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

Keywords

Androgenic Alopecia, Hair Diseases, Skin Diseases, Baldness, Alopecia, Hair Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Topical Herbal Solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Topical Minoxidil 5%

Other Intervention Name(s)

Minoxidil

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hair Diameter

Description

Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.

Time Frame

baseline, 12, 24, and 36 weeks

Secondary Outcome Measure Information:

Title

Patients Self - Assessment Questionnaire

Description

Time Frame

through study completion

Title

Adverse Events

Description

Incidence of adverse events such as itching, redness, inflammation etc

Time Frame

baseline, 12, 24, and 36 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Healthy men 18 to 50 years old

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials: