A clinical trial to evaluate the safety and efficacy of HAIRAL 7 in hair regrowth and in the treatment of dandruff and hair loss in female and male patients.

Completed

• Conditions: suffering from mild to moderate hair loss and/or Subjects suffering from mild to moderate dandruff.

• Registration Number: CTRI/2012/02/002461
• Lead Sponsor: ABS LABORATORIES

Brief Summary

This study is a prospective open labeled clinical trial which will evaluate the efficacy and safety of “HAIRAL 7†a natural product in hair regrowth and in thetreatment of dandruff and hair loss in female and male patients. Subjects to enter the study should have hairloss and/ or dandruff. All Subjects will be treated with HAIRAL 7 for 4 months.The study drug will be applied to the hair roots daily preferably in the nightfor 4 months.The treatment duration of study will be 4 Monthsfor each subject. this study is sponsored by ABS labs which is present at Hyderabad. The study will recruit 60 subjects within 4 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-24
• Study Completion: 2012-09-21
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males and females of age group 18-40 years Subjects who are suffering from mild to moderate hair loss and/or Subjects suffering from mild to moderate dandruff.
• Subjects who are willing to give written informed consent.

Exclusion Criteria

• Any dermatological condition of the scalp other than hair loss and /or dandruff.
• 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.
• Subjects with psoriasis/seborrheic dermatitis 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 hair loss) History of thyroid or other medical condition including polycystic ovary syndrome that might influence hair growth and loss, at the discretion of the Investigator.
• Subject had ever received radiation therapy to the scalp, or had chemotherapy within the past year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Assessment of adverse event	4 months
Investigator assessments	4 months
Reduction in dandruff score for applicable subjects	4 months
Secondary End points:	4 months
Primary Efficacy Endpoints:	4 months
Change in global photographic assessment for hair growth	4 months
Change in the investigator assessment score for Hair count each visit from enrollment onwards after treating with IP	4 months
- Subjective Assessment by patient using diary card evaluation	4 months

Secondary Outcome Measures

Name	Time	Method
Subjective Assessment by patient using diary card evaluation	- Assessment of adverse event

Trial Locations

Locations (1)

Revive skin & hair clinic; 🇮🇳 Bangalore, KARNATAKA, India

Revive skin & hair clinic

🇮🇳Bangalore, KARNATAKA, India

Dr Srinivas C

Principal investigator

080-42195246

drsriniskin@yahoo.com