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

• Sponsor: Farid Masoud (Other)
• Overall Status: Completed
• CT.gov ID: NCT03753113
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 2.6

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Nov 28, 2018
• Actual Primary Completion Date: Sep 2, 2019
• Actual Study Completion Date: Sep 2, 2019

Arms and Interventions

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 Names: 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 Names: Minoxidil

Outcome Measures

Primary Outcome Measures

1. Change in Hair Diameter [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 [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 [baseline, 12, 24, and 36 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, Sina Hospital	Tabriz	East Azerbaijan	Iran, Islamic Republic of

Sponsors and Collaborators

• Farid Masoud

Investigators

• 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)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Aug 8, 2018

More Information

Publications

None provided.

• Responsible Party: Farid Masoud, Principal Investigator, Tabriz University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03753113
• Other Study ID Numbers: TabrizUMS
• First Posted: Nov 26, 2018
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Farid Masoud, Principal Investigator, Tabriz University of Medical Sciences: Androgenic Alopecia; Hair Diseases; Skin Diseases; Baldness; Alopecia; Hair Loss
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Minoxidil

Study Results

Participant Flow

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks. Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks. Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.	The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks. Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment Group	Control Group	Total
Arm/Group Description	The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks. Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks. Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.	The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.45 (5.744)	33.67 (6.065)	33.04 (5.812)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	12 100%	12 100%	24 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	12 100%	12 100%	24 100%
Region of Enrollment (participants) [Number]
Iran	12 100%	12 100%	24 100%
Hair diameter (micrometer) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [micrometer]	52.75 (8.74)	54 (6.729)	53.38 (7.65)
Duration of androgenetic alopecia (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.58 (2.24)	4.42 (2.47)	4.5 (2.3)
Family history of androgenetic alopecia (Count of Participants)
Yes	10 83.3%	9 75%	19 79.2%
No	2 16.7%	3 25%	5 20.8%
Family history of the disease (Count of Participants)
Hypo/Hyperthyroidism	5 41.7%	3 25%	8 33.3%
Cardiovascular	2 16.7%	2 16.7%	4 16.7%
Diabetes	1 8.3%	1 8.3%	2 8.3%
None	4 33.3%	6 50%	10 41.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months	The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months
Measure Participants	12	12
Week 12	57.42 (8.88)	51.58 (7.67)
Week 24	60.92 (7.35)	51.17 (7.82)
Week 36	62.67 (7.19)	50.58 (7.38)

2. Secondary Outcome

Title	Patients Self - Assessment Questionnaire
Description	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.
Time Frame	through study completion

Outcome Measure Data

Analysis Population Description

All participants for whom data were collected at weeks 36.

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months	The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months
Measure Participants	12	12
Mean (Standard Deviation) [score on a scale]	1.25 (0.452)	2.58 (0.669)

3. Secondary Outcome

Title	Adverse Events
Description	Incidence of adverse events such as itching, redness, inflammation etc
Time Frame	baseline, 12, 24, and 36 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months	The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months
Measure Participants	12	12
scalp itching	1 8.3%	4 33.3%
scalp dryness	0 0%	2 16.7%
headache	0 0%	2 16.7%

Adverse Events

Time Frame	Adverse event data were collected from the beginning of the study until 9 months
Adverse Event Reporting Description	According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
Arm/Group Title	Treatment Group		Control Group
Arm/Group Description	The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months		The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months
All Cause Mortality
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Serious Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Eye disorders
Blurred vision	0/12 (0%)		0/12 (0%)
Musculoskeletal and connective tissue disorders
Chest pain	0/12 (0%)		0/12 (0%)
Nervous system disorders
Dizziness	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		8/12 (66.7%)
Nervous system disorders
headache	0/12 (0%)		2/12 (16.7%)
Skin and subcutaneous tissue disorders
scalp itching	1/12 (8.3%)		4/12 (33.3%)
scalp dryness	0/12 (0%)		2/12 (16.7%)

Limitations/Caveats

Small numbers of subjects

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.