Health Condition 1: L659- Nonscarring hair loss, unspecified Health Condition 2: L219- Seborrheic dermatitis, unspecified Health Condition 3: L670- Trichorrhexis nodosa Health Condition 4: L671- Variations in hair color
Conditions
Interventions
Intervention1: Kesh 21 Ayurvedic Hair Oil and Shampoo: Oil and Shampoo formulation containing 21 extracts of Ayurvedic herbs.
To be used for 9 weeks for management of hairfall, dandruff, premature gre
Sponsors
Ontop Pharmaceuticals Pvt Ltd
Aurous HealthCare Research and Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects between the age group of 21 to 45 years. 2. Subjects who are able to give written informed consent and ready to comply with the protocol. 3. Subjects with i. Active Alopecia, ii. Seborrheic Dermatitis of the Scalp - Total ASFS Score >= 16, iii. Premature Greying - â??Gray Hair Shade Card Assessment >=50% iv. Trichoptilosis (selected section of hair) 4. Subjects with a minimum hair length of 2 inches. 5. Subjects who are willing to maintain the same hair length and hair style from the time of enrolment till end of study, without anybleaching, dyeing, perming, straightening or other cosmetic treatments
Exclusion criteria
Exclusion criteria: 1. Subjects on topical treatment for alopecia, premature graying of the hair and seborrheic dermatitis for 8 weeks prior to enrollment. 2. Subjects with alopecia areata or other disorders/complications that lead to unusual hair fall or balding. 3. Subjects who are balding or bald. 4. Subjects who have used hair dye in the last 30 days or intend on regular use of hair dye during the course of the study 5. Subject with other dermatological disorders of the scalp that might interfere with the study evaluation. 6. Subjects with significant scalp scarring. 7. Subjects who have anemia or iron deficiency. 8. Subjects who have previously undergone hair transplantation procedures. 9. History of systemic or cutaneous malignancy or evidence of immunocompromised state. 10. Subjects with history of skin allergy. 11. Subjects on systemic steroids for more than 14 days within 2 months prior to enrollment. 12. Female subjects who are reported pregnant/planning a pregnancy or lactating. 13. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment. 14. Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrolment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ 60 second hair comb test: â?¥ 50 % reduction â?¢ Adherent Scalp Flaking Score: Reduction of 10 scores â?¢ Adherent Scalp Flaking Score: Reduction to 0 score â?¢ Grey Hair Shade Card Assessment: Reduction of 20% â?¢ Trichoptilosis: Repair/reduction of â?¥ 50 % â?¢ Objective Hair Assessment Questionnaire: Score of â?¥ 20 â?¢ Subject Self-Assessment and IP Feedback Questionnaire: Score of â?¥ 10Timepoint: â?¢ 60 second hair comb test: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Adherent Scalp Flaking Score: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Grey Hair Shade Card Assessment: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Trichoptilosis: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Objective Hair Assessment Questionnaire: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Subject Self Assessment and IP Feedback Questionnaire: 3rd wk, 6th wk, 9th wk | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ 60 second hair comb test: 25 - 49 % reduction â?¢ Adherent Scalp Flaking Score: Reduction of 6 scores â?¢ Grey Hair Shade Card Assessment: Reduction of 10 % â?¢ Trichoptilosis: Repair/reduction of 25 â?? 49 % â?¢ Objective Hair Assessment Questionnaire: Score of 15 - 19 â?¢ Subject Self-Assessment and IP Feedback Questionnaire: : Score of 5 - 9Timepoint: â?¢ 60 second hair comb test: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Adherent Scalp Flaking Score: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Grey Hair Shade Card Assessment: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Trichoptilosis: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Objective Hair Assessment Questionnaire: Baseline, 3rd wk, 6th wk, 9th wk â?¢ Subject Self Assessment and IP Feedback Questionnaire: 3rd wk, 6th wk, 9th wk | — |
Countries
India
Contacts
Public ContactDr VTSriraam MBBS MD Pharmacology
Aurous HealthCare Research & Development India Pvt Ltd
Outcome results
None listed