Clinical trial NCT03753113: Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
Official title: Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison With Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgenetic Alopecia
Keywords: Androgenic Alopecia
Hair Diseases
Skin Diseases
Baldness
Alopecia
Hair Loss
Lead sponsor: Tabriz University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hair Diameter
timeFrame: baseline, 12, 24, and 36 weeks
Secondary outcomes:
measure: Patients Self - Assessment Questionnaire
timeFrame: through study completion
measure: Adverse Events
timeFrame: baseline, 12, 24, and 36 weeks
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Department of Dermatology, Sina Hospital
state: East Azerbaijan
Study officials:
affiliation: Pharmacy Faculty
name: Farid Masoud, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmaceutics, Pharmacy Faculty
name: Yousef Javadzadeh, Ph.D
role: STUDY_DIRECTOR
affiliation: Department of Dermatology, Faculty of Medicine
name: Hamideh Azimi Alamdari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacognosy, Pharmacy Faculty
name: Solmaz Asnaashari, Ph.D
role: STUDY_DIRECTOR
affiliation: Department of Pharmaceutics, Pharmacy Faculty
name: Javad Shokri, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.