Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/ Female participants in general good health; 2. Participants in the age group 18-40 years (both ages inclusive). 3. Participants falling under Grade I-1 to II-1 or frontal of savins pictorial grading of female pattern hair loss or under Grade 2 to 4A of hair loss severity grade evaluated as per Norwood scale. 4. Participant with at least one of the following complaints Dry, damaged hair Brittle and thin hair Hair loss evident while combing or after washing Perceived reduced hair density Scalp-related complaints like itching, dandruff or irritation. 5. Willingness to maintain the same hair style, approximate length, and hair color throughout the study 6. Able to read, understand, and provide written (signed) informed before study starts. 7. Participants must be willing and able to comply study regimen and requirements in a timely manner.
Exclusion criteria
Exclusion criteria: 1. Participants who are undergoing hair growth treatment within 3 months before screening for the study. 2. Participants having any active scalp disease which may interfere with the study. 3. Prior use of scalp hair growth treatment (e.g. finasteride, minoxidil) within 6 months. 4. Participants on treatment for active acne. 5. Participants with a history or active phase of malignancy and chemotherapy. 6. Participants who have a history of alcoholism and/ or psychiatric disorders including trichotillomania. 7. Participants who take pharmaceutical products which cause hirsutism. 8. Participants on oral hair growth medications which will compromise the study. 9. Chronic illness which may influence the study 10. Participants participating in another similar cosmetic or therapeutic trial within the last two weeks. 11. Pregnant or lactating mothers. 12. Participant willing to continue his current regimen of vitamins, nutraceutical, herbal, or ayurvedic supplements for the duration of the study for hair health. 13. Participant on any medication known to cause hair loss or hair thinning (e.g. Isotretinoin). 14. Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness. 15. Known hypersensitivity to investigational product or its excipients. 16. Any prior hair growth procedures (e.g., hair transplant or laser). 17. Diagnosed with dermatologic conditions like eczema, fungal scalp infections, seborrheic dermatitis, recurrent herpes, pityriasis versicolor, psoriasis, pigmentary disorders (vitiligo, chloasma), chronic lupus erythematous. 18. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in the hair density and follicular density in the target area by Phototrichogram 2. Change in anagen to telogen ratio (A/T ratio) 3. Change in the hair growth rate in the target area by PhototrichogramTimepoint: screening, day 30, day 60 and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the number of terminal hairs, vellus hairs and and hair diameter in the target area by phototrichogram 2. Changes in number of hair shredded by 60 second hair comb test 3. Change in the number of shredded hairs after Modified hair wash test 4. Change in "Participant-Perceived Self-Hair Assessment Questionnaire" score 5. Change in visual analog scale (VAS) score for scalp related complaints like itching, dandruff or irritation reported by participants.Timepoint: screening, day 30, day 60 and day 90 | — |
Countries
India
Contacts
Mosaic Wellness Pvt Ltd