Androgenetic Alopecia
Conditions
Keywords
Androgenic Alopecia, Hair Diseases, Skin Diseases, Baldness, Alopecia, Hair Loss
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.
Interventions
DRUGTopical Herbal Solution
Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.
Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
Sponsors
Farid Masoud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Adverse Events | baseline, 12, 24, and 36 weeks | Incidence of adverse events such as itching, redness, inflammation etc |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 32.45 years STANDARD_DEVIATION 5.744 | 33.67 years STANDARD_DEVIATION 6.065 | 33.04 years STANDARD_DEVIATION 5.812 |
| Duration of androgenetic alopecia | 4.58 years STANDARD_DEVIATION 2.24 | 4.42 years STANDARD_DEVIATION 2.47 | 4.5 years STANDARD_DEVIATION 2.3 |
| Family history of androgenetic alopecia No | 2 Participants | 3 Participants | 5 Participants |
| Family history of androgenetic alopecia Yes | 10 Participants | 9 Participants | 19 Participants |
| Family history of the disease Cardiovascular | 2 Participants | 2 Participants | 4 Participants |
| Family history of the disease Diabetes | 1 Participants | 1 Participants | 2 Participants |
| Family history of the disease Hypo/Hyperthyroidism | 5 Participants | 3 Participants | 8 Participants |
| Family history of the disease None | 4 Participants | 6 Participants | 10 Participants |
| Hair diameter | 52.75 micrometer STANDARD_DEVIATION 8.74 | 54 micrometer STANDARD_DEVIATION 6.729 | 53.38 micrometer STANDARD_DEVIATION 7.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 12 Participants | 24 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Iran | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 12 | 8 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change in Hair Diameter
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Change in Hair Diameter | Week 24 | 60.92 micrometer | Standard Deviation 7.35 |
| Treatment Group | Change in Hair Diameter | Week 36 | 62.67 micrometer | Standard Deviation 7.19 |
| Treatment Group | Change in Hair Diameter | Week 12 | 57.42 micrometer | Standard Deviation 8.88 |
| Control Group | Change in Hair Diameter | Week 24 | 51.17 micrometer | Standard Deviation 7.82 |
| Control Group | Change in Hair Diameter | Week 36 | 50.58 micrometer | Standard Deviation 7.38 |
| Control Group | Change in Hair Diameter | Week 12 | 51.58 micrometer | Standard Deviation 7.67 |
Secondary
Adverse Events
Incidence of adverse events such as itching, redness, inflammation etc
Time frame: baseline, 12, 24, and 36 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Adverse Events | headache | 0 Participants |
| Treatment Group | Adverse Events | scalp itching | 1 Participants |
| Treatment Group | Adverse Events | scalp dryness | 0 Participants |
| Control Group | Adverse Events | scalp itching | 4 Participants |
| Control Group | Adverse Events | scalp dryness | 2 Participants |
| Control Group | Adverse Events | headache | 2 Participants |
Secondary
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.
Time frame: through study completion
Population: All participants for whom data were collected at weeks 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Patients Self - Assessment Questionnaire | 1.25 score on a scale | Standard Deviation 0.452 |
| Control Group | Patients Self - Assessment Questionnaire | 2.58 score on a scale | Standard Deviation 0.669 |