Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects in the age group of 18-45 years 2. Healthy skin in the test areas 3. Subjects willing and capable to follow the study rules and a fixed schedule 4. Ability of giving consent for participation in the study 5. Subjects with good health in general and good mental condition 6. Subjects who present at least 10 inflammatory lesions 7. Oily skin on the face
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Subjects who present severe acne 3. Subjects who present more than two nodular lesions 4. Subjects who changed their oral contraception method up to three months before the study beginning 5. Subjects who did acne hormonal treatment less than 6 months before the study 6. Subjects who did oral isotretinoine treatment less than 1 month before the study 7. Subjects who did topical acne treatment less than 90 months before the study 8. Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling) 9. Subjects who did treatment with antibiotics within the last 4 months 10. Simultaneous participation in different studies from external research institutes on the same test sites 11. Hypersensitivity to any of the ingredients of the test product. 12. Pregnant or lactating women 13. Patients on steroid therapy or any other immunomodulatory agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of Patients with a Score of 0 or 1 on GAAS Percentage of patients with minimal or no acne on the GAAS scale. 2.Change in Inflammatory Lesions 3.Change in Noninflammatory Lesions Change in the number of noninflammatory lesions from baseline. 4.Change in Total Lesion Counts Overall change in facial lesion count from baseline. 5.Microbiological Swab Swab taken from acne lesion site at baseline and post-study (day 15 or 30). 6.Percentage Reporting Very Good or Excellent on ASIS Item 10: Percentage of patients rating acne symptom impact as Very Good or Excellent. 7.Overall Improvement in Skin Health. 8. Burning, Itching, Tingling, Stinging Scores. 9.Sebumetric Analysis. 10.Corneometer Analysis 11.Dermatology Life Quality Index 12.Ease of Use. 13.Pre and Post Study Photographic AssessmentsTimepoint: DAy 0, day 15 and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| •Patient and Investigator Feedbacks will be obtained •Adverse event monitoring Timepoint: DAy 0, day 15 and day 30 | — |
Countries
India
Contacts
DK Elite Health Care Centre