To evaluate the Keratex Oil for hair growth, hair density and overall improvement inhair & scalp condition in healthy human subjects
- Registration Number
- CTRI/2016/09/007275
- Lead Sponsor
- Dabur India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
•Male and female subjectsâ?? in general good health.
• Subjects in the age group 18-55 years (both the ages
inclusive).
• Subjects willing to give a written informed consent and
agree to come for a regular follow up visit.
• Female and Male Subjects falling under Grade 3 - Grade 8 of hair loss severity grade evaluated as per standard photo numeric 10 point scale
• Subjects willing to abide by and comply with the study
protocol.
• Subjects who have not participated in a similar
investigation in the past two weeks.
• Subjects complaining of hair fall and damage.
• Healthy volunteers with no known allergy as established
by medical history.
• Subjects who are not on crash dieting.
• Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration.
• Literate subjects only.
• Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
• Subjects having any active scalp disease which may interfere in the study.
• Subjects who have treatments of cancer chemotherapy last 6 months before starting study or have a plan to do treatments of them during study terms.
• Subjects who have history of alcoholism and/ or
psychiatric disorder including trichotillomania.
• Subjects who have had hair transplant.
• Subjects who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
• A known history or present condition of allergic
response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
• Subjects on oral medications which will compromise the study.
• Subjects who are pregnant or lactating or nursing as established with medical history.
• Chronic illness which may influence the cutaneous state.
• Subjects participating in other similar cosmetic or therapeutic trial within last two weeks
• Subject having history of migraine headache.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ To evaluate the efficacy of Keratex Oil in hair growth <br/ ><br>in comparison to baseline and control. <br/ ><br>â?¢ To evaluate the efficacy of Keratex Oil in hair density <br/ ><br>in comparison to baseline and control.Timepoint: 8 Weeks
- Secondary Outcome Measures
Name Time Method Safety of Investigational product by assessment of site application reaction by dermatologist and subjects.Timepoint: 8 weeks