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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Androgenetic Alopecia
Interventions Drug: Topical Herbal Solution
Drug: Topical Minoxidil 5%
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group Control Group
Hide 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
Arm/Group Title Treatment Group Control Group Total
Hide 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 Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
At the Week 0 administration, subject demographics, hair diameter, and duration of androgenetic alopecia acquired.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
32.45  (5.744) 33.67  (6.065) 33.04  (5.812)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
12
 100.0%
24
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
 100.0%
12
 100.0%
24
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iran Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Hair diameter  
Mean (Standard Deviation)
Unit of measure:  Micrometer
Number Analyzed 12 participants 12 participants 24 participants
52.75  (8.74) 54  (6.729) 53.38  (7.65)
Duration of androgenetic alopecia  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
4.58  (2.24) 4.42  (2.47) 4.5  (2.3)
Family history of androgenetic alopecia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Yes
10
  83.3%
9
  75.0%
19
  79.2%
No
2
  16.7%
3
  25.0%
5
  20.8%
Family history of the disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hypo/Hyperthyroidism
5
  41.7%
3
  25.0%
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
  50.0%
10
  41.7%
1.Primary Outcome
Title Change in Hair Diameter
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Control Group
Hide 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

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: micrometer
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for whom data were collected at weeks 36.
Arm/Group Title Treatment Group Control Group
Hide 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

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.25  (0.452) 2.58  (0.669)
3.Secondary Outcome
Title Adverse Events
Hide Description Incidence of adverse events such as itching, redness, inflammation etc
Time Frame baseline, 12, 24, and 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Control Group
Hide 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

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
scalp itching
1
   8.3%
4
  33.3%
scalp dryness
0
   0.0%
2
  16.7%
headache
0
   0.0%
2
  16.7%
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
Hide 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 (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Eye disorders     
Blurred vision   0/12 (0.00%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders     
Chest pain *  0/12 (0.00%)  0/12 (0.00%) 
Nervous system disorders     
Dizziness *  0/12 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   8/12 (66.67%) 
Nervous system disorders     
headache *  0/12 (0.00%)  2/12 (16.67%) 
Skin and subcutaneous tissue disorders     
scalp itching *  1/12 (8.33%)  4/12 (33.33%) 
scalp dryness *  0/12 (0.00%)  2/12 (16.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Farid Masoud
Organization: Tabriz University of Medical Sciences
Phone: +989036859062
EMail: faridmasoud@gmail.com
Layout table for additonal information
Responsible Party: Farid Masoud, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03753113    
Other Study ID Numbers: TabrizUMS
First Submitted: November 21, 2018
First Posted: November 26, 2018
Results First Submitted: January 18, 2020
Results First Posted: March 16, 2020
Last Update Posted: March 16, 2020