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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03753113
Other study ID # TabrizUMS
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 28, 2018
Est. completion date September 2, 2019

Study information

Verified date March 2020
Source Tabriz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 2, 2019
Est. primary completion date September 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Iran, Islamic Republic of Department of Dermatology, Sina Hospital Tabriz East Azerbaijan

Sponsors (1)

Lead Sponsor Collaborator
Farid Masoud

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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. through study completion
Secondary Adverse Events Incidence of adverse events such as itching, redness, inflammation etc baseline, 12, 24, and 36 weeks
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