A study to find the efficacy and safety of BioMinox A DD for the treatment of dandruff and hair loss
- Registration Number
- CTRI/2012/08/002869
- Lead Sponsor
- Sante Mernaud Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
•Males and females of age group 18-50 years
•Subjects who are suffering from mild to moderate dandruff and hair loss.
•Subjects who are willing to give written informed consent
•Any dermatological condition of the scalp other than hair loss and /or dandruff.
•Any prior hair growth procedures (e.g., hair transplant or laser)
•History of alcohol or drug addiction
•History of skin allergy
•Any active skin infection in the scalp area or scarring in the target area.
•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 trial.
•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.
•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 â?¢Reduction in dandruff score [Baseline and visit 4] <br/ ><br>â?¢Change in investigator global assessment for hair loss and dandruff (Mild-1, Moderate-2 and severe-3) [Baseline and visit 4] <br/ ><br>â?¢Changes in hair objective hair assessments for hair loss- Hair density and Comb test [Baseline and visit 4]. <br/ ><br>Timepoint: Baseline and visit 4 <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Subjective Assessment by patient using questionnaire [Baseline and visit 4] <br/ ><br>â?¢Assessment of adverse events in all visits <br/ ><br>Timepoint: Baseline and visit 4