Clinical Trial Details (PDF Generation Date :- Fri, 21 Dec 2018 19:27:12 GMT) CTRI Number Last Modified On 06/01/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/02/002456 [Registered on: 27/02/2012] - Trial Registered Retrospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial A clinical trial to study the safety and efficacy of topical application of study drug for the treatment of male pattern baldness Open Label Phase II study to evaluate the Safety and Efficacy of topical application of study drug for the treatment of mild to moderate Androgenic Alopecia in Male Patients Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details of Principal Investigator Affiliation MCI No: 20033 Affiliation Consultant- Dermatologist, Dermatopathologist, Hair transplant surgeon G cross, 7th main, Subbanna Garden, Vijaynagar,Bangalore Bangalore Details Contact Person (Scientific Query) G cross, 7th main, Subbanna Garden, Vijaynagar,Bangalore Details Contact Person (Public Query) Affiliation Details Contact Person (Public Query) G cross, 7th main, Subbanna Garden, Vijaynagar,Bangalore page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria > Kumar Organic products Ltd Type of Sponsor List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Kumar Organic products Ltd : Kumar Organic products Ltd.Plot No.36,Road No. 3 Road No.3&5, Jigani Industrial Area, Anekal Taluk, Bangalore, Karnataka,. 562 106 Pharmaceutical industry-n of Site Site Phone// Dr. Venkat Charmalaya-centre for advanced dermatology Dr. Venkat Charmalaya-centre for advanced dermatology, 3437,1st G cross, 7th main, Subbanna Garden, Vijaynagar,Bangalore Bangalore 080-23392788 mysorevenkat@hotmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethical Committee Status Not Applicable Health Type Healthy Human Volunteers Approved 20/12/2011 No Date No Date Specified Condition androgenic alopecia Type Details Intervention FD/SBF/MX-40 1 ml to be applied twice daily on the bald area for 4 months. Intervention FD/WBF/KX-38- Aminexil 1.5% active+multifunctional compound-amino acids 1mL to be applied twice daily in morning and evening on bald area of scalp Intervention FD/SBF/PY-39 1 ml to be applied on the bald area twice daily. Intervention FD/WBF/MX-36 1ml to be applied on the bald area twice daily. Intervention FD/WBF/PY-37 i ml to be applied twice daily on the bald area. Comparator Agent none no comparator Age From 25.00 Year(s) Inclusion Criteria page 2 / 5
Age To Gender Details 45.00 Year(s) Male 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 Details 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 buzz cut hairstyle, defined as hair cut to less than one inch in page 3 / 5
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 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization An Open list of random numbers Open Label Primary Outcome Outcome Timepoints - 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 120 days (Day 0, Day 30, Day 60, Day 90 and Day 120) Secondary Outcome Outcome Timepoints Assessment of dermal tolerability (Designated as 6 months safety issue) Patients assessment of hair growth and loss by hair growth questionnaire. Any adverse event reported voluntarily, observed or enquired. Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Total Sample Size=60 Sample Size from =60 02/01/2012 No Date Specified Years=0 Months=6 Days=0 Not Applicable Completed page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Trial () Publication Details Brief Summary This is a open labeled randomized pilot, 5 arm study to evaluate the efficacy and safety of minoxidil 5%, kopyrrol 5%, minoxidil 3% + active multi-functional amino acid, kopyrrol 3% + multi-functional amino acid, aminexil 1.5% + multi-functional amino acid for the treatment of mild to moderate androgenic alopecia in 60( 12 in each arm) male patients. page 5 / 5