None listed
Conditions
Interventions
Intervention1: FD/SBF/MX-40
: 1 ml to be applied twice daily on the bald area for 4 months.
Intervention2: FD/WBF/KX-38- Aminexil 1.5% active+Multifunctional compound-Amino acids: 1mL to be applied tw
Sponsors
Kumar Organic products Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change in the investigator assessment score for Hair density, hair growth rate, and hair diameter and scalp coverage, each visit from enrollment onwards after treating with IP Change in global photographic assessment for hair growth Timepoint: 120 days (Day 0, Day 30, Day 60, Day 90 and Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of dermal tolerability (Designated as safety issue) Patients assessment of hair growth and loss by hair growth questionnaire. Any adverse event reported voluntarily, observed or enquired. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Venkat
Outcome results
None listed