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The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Herbal Solution | Drug | Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hair Diameter | Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer. | baseline, 12, 24, and 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Healthy men 18 to 50 years old
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| Name | Affiliation | Role |
|---|---|---|
| Farid Masoud, PharmD | Pharmacy Faculty | Principal Investigator |
| Yousef Javadzadeh, Ph.D | Department of Pharmaceutics, Pharmacy Faculty | Study Director |
| Hamideh Azimi Alamdari, MD | Department of Dermatology, Faculty of Medicine | Principal Investigator |
| Solmaz Asnaashari, Ph.D | Department of Pharmacognosy, Pharmacy Faculty | Study Director |
| Javad Shokri, Ph.D | Department of Pharmaceutics, Pharmacy Faculty | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Sina Hospital | Tabriz | East Azerbaijan Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33112463 | Derived | Masoud F, Alamdari HA, Asnaashari S, Shokri J, Javadzadeh Y. Efficacy and safety of a novel herbal solution for the treatment of androgenetic alopecia and comparison with 5% minoxidil: A double-blind, randomized controlled trial study. Dermatol Ther. 2020 Nov;33(6):e14467. doi: 10.1111/dth.14467. Epub 2020 Nov 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
At the Week 0 administration, subject demographics, hair diameter, and duration of androgenetic alopecia acquired.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hair Diameter | Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer. | Posted | Mean | Standard Deviation | micrometer | baseline, 12, 24, and 36 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 9 months Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred vision | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| scalp itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Small numbers of subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Farid Masoud | Tabriz University of Medical Sciences | +989036859062 | faridmasoud@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 8, 2018 | Jan 28, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Topical Minoxidil 5% | Drug | Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks. |
|
|
| through study completion |
| Adverse Events | Incidence of adverse events such as itching, redness, inflammation etc | baseline, 12, 24, and 36 weeks |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hair diameter | Mean | Standard Deviation | micrometer |
|
| Duration of androgenetic alopecia | Mean | Standard Deviation | years |
|
| Family history of androgenetic alopecia | Count of Participants | Participants |
|
| Family history of the disease | Count of Participants | 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. | All participants for whom data were collected at weeks 36. | Posted | Mean | Standard Deviation | score on a scale | through study completion |
|
|
|
| Secondary | Adverse Events | Incidence of adverse events such as itching, redness, inflammation etc | Posted | Count of Participants | Participants | baseline, 12, 24, and 36 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | 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 9 months | 0 | 12 | 0 | 12 | 8 | 12 |
| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| scalp dryness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
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| headache |
|