Health Condition 1: L659- Nonscarring hair loss, unspecified Health Condition 2: L671- Variations in hair color
Conditions
Interventions
None listed
Sponsors
Mr Dileep Kumar
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult Subjects aged between 18 and 35 years old -both ages and all sexes inclusive- 2. Subjects with active Alopecia and Premature Graying of Hair 3. Subjects with a minimum hair length of 2 inches and willing to maintain the minimum length, hair style until end of study 4. Subjects who are willing to refrain from undergoing any hair treatments not limited to hair spa, dyeing, perming, straightening, keratin treatment or any other cosmetic treatments. 5. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects on topical treatments for alopecia and premature graying of hair for 8 weeks prior to enrolment. 2. Subjects with alopecia areata or other disorders or complications that lead to unusual hair fall or balding. 3. Subjects who are naturally or genetically 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. Subjects with other dermatological disorders of the scalp that might interfere with the study evaluation. 6. Subjects with significant scalp scarring 7. Subjects with known history of anemia or iron deficiency 8. Subjects with history of systemic malignancy or evidence of immunocompromised state of any type less than 5 years at the time of screening 9. Subjects who are planning a pregnancy and or currently breastfeeding. 10. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment. 11. Any significant medical condition -e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor -e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation. 12. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 13. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 60 Second Hair Comb Test: Reduction of ââ?°Â¥50% in shedding range Graying Severity Score: Reduction of ââ?°Â¥5 scores Patient Global Impression of Change Scale: Score of ââ?°Â¥4. Timepoint: 60 Second Hair Comb Test: Day1, Day22 and Day45 Graying Severity Score: Day1, Day22 and Day45 Patient Global Impression of Change Scale: Day45 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed