None listed
Conditions
Interventions
Intervention1: Dheedhi Herbal Kajal: Kajal (eyeliner) containing 12 herbal extracts.
The Kajal is to be applied on the upper and lower lashline twice a day - morning and evening.
The total duration of
Sponsors
Dhathri Ayurveda Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects between the age group of 18 to 35 years. 2. Subjects who are able to give written informed consent and ready to comply with the protocol. 3. Subjects who are regular users of kajal or eye liner
Exclusion criteria
Exclusion criteria: 1. Subjects who are visually impaired or having underlying conditions that potentially impairs their vision. 2. Subjects with known history of allergies or specific allergic reactions upon using ophthalmic cosmetic products. 3. Subjects with presenting ophthalmic conditions like dry eye, cataract, conjunctivitis etc. 4. Subjects who are regular users of prescription or cosmetic contact lens. 5. Subjects who have dark circles under their eyes. 6. Subjects who are reported pregnant/planning a pregnancy or lactating. 7. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment. 8. Subjects, who in the opinion of the Investigator or the Expert Dermatologist are not eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Objective Ophthalmic Scoring Scale : Total score of 0 or 4 2. Dermatologist Assessment Questionnaire: Total score of 0 or 4 3. Global Eyelash Assessment Scale: â??Very Markedâ?? or score 4 4. Subjective Self Assessment Questionnaire: Total Score of 15 5. Subject IP Feedback Questionnaire: Total Score of 10 6. IP Compliance Details: Smudge Free Hours: 8-10h Onset of Cooling Time: 0-5 min Lasting of Cooling Effect: 10-15 min Smearing/Fading of IP: 8-10h Timepoint: 1. Objective Ophthalmic Scoring Scale:Visit 1,2,3 with a gap of 2 wks 2. Dermatologist Assessment Questionnaire:Visit 1,2,3 with a gap of 2 wks 3. Global Eyelash Assessment Scale:Visit 1,2,3 with a gap of 2 wks 4. Subjective Self Assessment Questionnaire:Visit 1,2,3 with a gap of 2 wks 5. Subject IP Feedback Questionnaire:Visit 1,2,3 with a gap of 2 wks 6. IP Compliance Details: Smudge Free Hours,Onset of Cooling Time,Lasting of Cooling Effect,Smearing/Fading of IP: Daily for 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Ophthalmic Scoring Scale : Total score of 8 2. Dermatologist Assessment Questionnaire: Total score of â?¤8 3. Global Eyelash Assessment Scale: â??Markedâ?? or score 3 4. Subjective Self Assessment Questionnaire: Total Score of 10 5. Subject IP Feedback Questionnaire: Total Score of 5 6. IP Compliance Details: Smudge Free Hours: 6-8 h Onset of Cooling Time: 5-10 min Lasting of Cooling Effect: 5-10 min Smearing/Fading of IP: 6-8hTimepoint: 1. Objective Ophthalmic Scoring Scale:Visit 1,2,3 with a gap of 2 wks 2. Dermatologist Assessment Questionnaire:Visit 1,2,3 with a gap of 2 wks 3. Global Eyelash Assessment Scale:Visit 1,2,3 with a gap of 2 wks 4. Subjective Self Assessment Questionnaire:Visit 1,2,3 with a gap of 2 wks 5. Subject IP Feedback Questionnaire:Visit 1,2,3 with a gap of 2 wks 6. IP Compliance Details: Smudge Free Hours,Onset of Cooling Time,Lasting of Cooling Effect,Smearing/Fading of IP: Daily for 1 month | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Poly Clinic
Outcome results
None listed