A single Arm, Multicenter, Prospective, Clinical study to evaluate efficacy and safety of MAR/HO-2 oil in mild to moderate Hair loss in females
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Marico Ltd
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Assessment of efficacy of MAR/HO-02 oil in mild to moderate hair loss in females (by running finger test and comb test)
Study Overview
Brief Summary
Thisis a single Arm, Multicenter, Prospective, Clinical study to evaluate efficacyand safety of MAR/HO-2 oil in mild to moderate Hair loss in females. The studywill be conducted in 50 female subjects. The study will be conducted at 2centers in India. Subjects will be asked to apply approximately 5-10 ml ofMAR/HO-2 hair oil every day for 60 days. The primary outcome will be to assessefficacy of MAR/HO-02 oil in mild to moderate hair loss in females by runningfinger test and comb test. (Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60).The secondary outcomes will be to assess effect of MAR/HO-02 on quality of hairbased on subject questionnaire including effect on dandruff, greying and hairgrowth, global assessment of overall change in hair loss by physician and by subjectand safety by observing episodes, severity and duration of any allergicreactions and adverse events (Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60)
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Subjects suffering from mild to moderate hair loss (by comb test).
- •Subjects who are infrequent hair oil users
- •Subjects who are willing to give informed consent and ready to comply with the protocol
- •Subjects who are ready to provide regular follow ups till the completion of the study.
Exclusion Criteria
- •Subjects with severe Hair fall due to any clinically significant disorders like anemia, thyroid disorders etc.
- •Subject with severe dermatological disorders of the scalp that might interfere with the study evaluation
- •Subjects with recent disease history like, malaria, typhoid, jaundice and scalp diseases and subjects who in the opinion of the investigator are not eligible for enrollment in the clinical study
- •Subjects who have regularly used anti-hair fall treatment with hair oils over the last 6 months.
- •Subjects who have previously undergone hair transplantation procedures
- •Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment.
- •Subjects on immunosuppressive drugs
- •Known cases of Hypersensitivity to hair oil contents
- •Subjects who have participated in any other clinical study since last 3 months
- •Subjects who are reported pregnant or planning a pregnancy or lactating.
- •Menopausal Women.
Outcomes
Primary Outcomes
Assessment of efficacy of MAR/HO-02 oil in mild to moderate hair loss in females (by running finger test and comb test)
Time Frame: Day -5, Day 0, Day 15, Day 30, Day 45 and Day 60
Secondary Outcomes
- 1.Assessment of effect of MAR/HO-02 on quality of hair based on subject questionnaire including effect on dandruff, greying and hair growth.(2.Global assessment of overall change in hair loss by the physician)