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Completed

NCT Number: NCT03753113

Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%

The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Department of Dermatology, Sina Hospital

Tabriz, East Azerbaijan Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Herbal Solution

Drug

Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.

Topical minoxidil 5%

Drug

Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.

Other names: Minoxidil

Primary outcomes

  1. Change in Hair Diameter

    Time frame: baseline, 12, 24, and 36 weeks

    Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.

Secondary outcomes

  1. Patients Self - Assessment Questionnaire

    Time frame: 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.

  2. Adverse Events

    Time frame: baseline, 12, 24, and 36 weeks

    Incidence of adverse events such as itching, redness, inflammation etc

Sponsors and collaborators

Lead sponsor

Farid Masoud

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2018
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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