A clinical trial to study the safety and efficacy of topical application of study drug for the treatment of male pattern baldness
- Registration Number
- CTRI/2012/02/002456
- Lead Sponsor
- Kumar Organic products Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Men aged 25 to 45 years, in general good health
-Mild to moderate male-pattern baldness (androgenic alopecia), preferably on the top back of the skull.
-Willingness to maintain the same hair style, approximate length, and hair color throughout the study
-Subject willing to continue his current regimen of vitamins and nutritional
supplements and not start any new vitamins or nutritional supplements for the
duration of the study.
- Able to read, understand, and provide written (signed) informed consent after the
nature of the study has been fully explained and before any procedures dictated by
this protocol were performed.
- Subjects must be willing and able to comply with follow-up requirements in a timely manner.
Any dermatological condition of the scalp other than androgenic alopecia (males)
-Prior use of scalp hair growth treatment (e.g., finasteride, minoxidil) within 6 months
-Any prior hair growth procedures (e.g., hair transplant or laser)
-History of alcohol or drug addiction
-History of skin allergy
-Regular use of medication which might interfere with the results of the study
- Subject had used phytotherapy (e.g., saw palmetto) within eight weeks prior to
baseline.
-Any active skin infection in the scalp area or scarring in the target area.
-Photosensitivity to laser light.
- Subject had used Accutane® in the previous year. ( Isotretinoin (sold as Accutane or roaccutane) Isotretinoin is an isomer of Vitamin A (13-cis-Vitamin A acid). Hair thinning or hair loss on the other hand, is one of the most commonly reported post accutane side effects.
-Medications with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide), topical estrogen, tamoxifen, anabolic steroids, oral glucocorticoids (or other medications at the discretion of the Investigator.(these are the Medications for hairloss)
-History of thyroid or other medical condition that might influence hair growth and
loss, at the discretion of the Investigator.
- Subject had â??buzzâ?? cut hairstyle, defined as hair cut to less than one inch in
length.
- Subject had light blonde hair, at the discretion of the investigator.
- Subject had ever received radiation therapy to the scalp, or had chemotherapy
within the past year.
.
- Subject had participated in any investigational study within the 30 days prior to
randomization.
-A history or the presence of any serious and/or chronic medical condition(s)
[including psychiatric illnesses] which, in the opinion of the investigator, may
cause harm to the individual and/or compromise/confound the study results.
Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).
Subjects unwilling or unable to comply with the study procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method