Trial Outcomes & Findings for Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5% (NCT NCT03753113)
NCT ID: NCT03753113
Last Updated: 2020-03-16
Results Overview
Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
24 participants
Primary outcome timeframe
baseline, 12, 24, and 36 weeks
Results posted on
2020-03-16
Participant Flow
Participant milestones
| Measure |
Treatment Group
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.
|
Control Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
Baseline characteristics by cohort
| Measure |
Treatment Group
n=12 Participants
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.
|
Control Group
n=12 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.45 years
STANDARD_DEVIATION 5.744 • n=5 Participants
|
33.67 years
STANDARD_DEVIATION 6.065 • n=7 Participants
|
33.04 years
STANDARD_DEVIATION 5.812 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Iran
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Hair diameter
|
52.75 micrometer
STANDARD_DEVIATION 8.74 • n=5 Participants
|
54 micrometer
STANDARD_DEVIATION 6.729 • n=7 Participants
|
53.38 micrometer
STANDARD_DEVIATION 7.65 • n=5 Participants
|
|
Duration of androgenetic alopecia
|
4.58 years
STANDARD_DEVIATION 2.24 • n=5 Participants
|
4.42 years
STANDARD_DEVIATION 2.47 • n=7 Participants
|
4.5 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Family history of androgenetic alopecia
Yes
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Family history of androgenetic alopecia
No
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Family history of the disease
Hypo/Hyperthyroidism
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Family history of the disease
Cardiovascular
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Family history of the disease
Diabetes
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Family history of the disease
None
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12, 24, and 36 weeksChange in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
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
|
Control Group
n=12 Participants
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
|
|---|---|---|
|
Change in Hair Diameter
Week 12
|
57.42 micrometer
Standard Deviation 8.88
|
51.58 micrometer
Standard Deviation 7.67
|
|
Change in Hair Diameter
Week 24
|
60.92 micrometer
Standard Deviation 7.35
|
51.17 micrometer
Standard Deviation 7.82
|
|
Change in Hair Diameter
Week 36
|
62.67 micrometer
Standard Deviation 7.19
|
50.58 micrometer
Standard Deviation 7.38
|
SECONDARY outcome
Timeframe: through study completionPopulation: All participants for whom data were collected at weeks 36.
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.
Outcome measures
| Measure |
Treatment Group
n=12 Participants
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
|
Control Group
n=12 Participants
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
|
|---|---|---|
|
Patients Self - Assessment Questionnaire
|
1.25 score on a scale
Standard Deviation 0.452
|
2.58 score on a scale
Standard Deviation 0.669
|
SECONDARY outcome
Timeframe: baseline, 12, 24, and 36 weeksIncidence of adverse events such as itching, redness, inflammation etc
Outcome measures
| Measure |
Treatment Group
n=12 Participants
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
|
Control Group
n=12 Participants
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
|
|---|---|---|
|
Adverse Events
scalp itching
|
1 Participants
|
4 Participants
|
|
Adverse Events
scalp dryness
|
0 Participants
|
2 Participants
|
|
Adverse Events
headache
|
0 Participants
|
2 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=12 participants at risk
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
|
Control Group
n=12 participants at risk
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
|
|---|---|---|
|
Eye disorders
Blurred vision
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
Other adverse events
| Measure |
Treatment Group
n=12 participants at risk
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
|
Control Group
n=12 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
scalp itching
|
8.3%
1/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
33.3%
4/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
|
Skin and subcutaneous tissue disorders
scalp dryness
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
16.7%
2/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
|
Nervous system disorders
headache
|
0.00%
0/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
16.7%
2/12 • Adverse event data were collected from the beginning of the study until 9 months
According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.
|
Additional Information
Dr. Farid Masoud
Tabriz University of Medical Sciences
Phone: +989036859062
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place