None listed
Conditions
Interventions
Intervention1: Scalp lotion: The product should be applied by the subject at home twice daily, once in the morning and once at night for a duration of 6 months. Each time, ten pumps of the test produc
Sponsors
Ichimaru Pharcos Co Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects in general good health. 2. Female subjects in the age group 30 to 55 years (both the ages inclusive) 3. Subjects willing to give a written informed consent and agree to come for a regular follow up visit. 4. Subjects falling under Grade 3 to Grade 6 of hair loss severity grade evaluated as per photo numeric 10 point scale (MSCR Scale). 5. Subjects with 15-25% of grey hair (considering overall scalp area) based on dermatologist discretion. 6. Subjects who are non-regular users of hair colour or hair dye and have not applied henna or hair colour etc for the past 1 month or more before screening visit (self-declared). 7. Subjects willing to apply TP as per instruction and they will not use any other hair product during the study period. 8. Subjects complaining of hair fall and damage.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone hair growth treatment within 1 month before screening into the study. 2. Subjects using medicated oil/shampoo etc. for treatment of grey hair/ hair fall will be excluded 3. Subjects having any active scalp disease which may interfere in the study dermatologist s judgement. 4. Subjects who have taken chemotherapy for cancer in the last 6 months prior to start of the study or have a plan to do treatments during study. 5. Subjects who have history of alcoholism and/or psychiatric disorder including trichotillomania. 6. Subjects who have had hair transplant. 7. A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products. 8. Subjects on oral medications which will compromise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in grey hair (%) in comparison to baseline by cutiscope imaging, trichoscan analysis & dermatological evaluation at 3-months and 6-months time points compared to baseline. 2. Improvement in hair growth by cutiscope imaging, trichoscan analysis and dermatological evaluation at 3-months and 6-months time points compared to baseline. 3. Improvement in hair density and thickness by Deno-lite imaging (caselite) and dermatological evaluation at 3-months and 6-months time points compared to baseline. 4. Overall improvement in the condition of hair in comparison to baseline. 5. Safety evaluation of test products Timepoint: Baseline, 3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall improvement in the condition of hair in comparison to baseline. 2. Safety evaluation of test productsTimepoint: Baseline, 3 months, 6 months | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed