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 isotretinoïne 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 (None) or 1 (Minimal) on the 5- point Global Acne Assessment Score (GAAS) 2)Change From Baseline in Inflammatory Facial Lesion Counts 3)Change From Baseline in Noninflammatory Facial Lesion Counts 4) From Baseline in Total Lesion Counts 5)Microbiological Swab from the Acne lesion site will be taken 6)Instrumental Assessment: -Sebumetric analysis (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application) and also post study at day 30. - Corneometer analysis for skin Moisturization (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application) 7) Dermatology Life Quality Index (DLQI) questionnaire Timepoint: Day 0, 15 and 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient and Investigator Feedbacks will be obtained Adverse event monitoringTimepoint: BAseline, Day 0, Day 15,Day 30 | — |
Countries
India
Contacts
Thirumalai medical Centre, ki3