None listed
Conditions
Interventions
Intervention1: TLS-SA23: One capsule to be taken twice a day after meals for 8 weeks
Control Intervention1: NA: NA
Sponsors
Transformative Learning Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Each subject with mild to moderate acne and with oily/ acne prone skin (based on lesion count) 2. Each subject with oily acne prone skin, sebum casual level on forehead > 90µg/cm2 (mean) 3. Subjects having acne based on IGA Scale. 4. Subjects having spots, PIH/uneven skin tone and enlarged pores 5. Subjects with other skin concern like blemishes, rashes etc. 6. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face. 7. Subject who agrees not to use any other product/treatment/home remedy/except the provided products on their face during the study period other than the test product. 8.Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period. 9.Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face). 10.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up. 11. Subjects willing to abide by and comply with the study protocol. 12. Subject to agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA imaging.
Exclusion criteria
Exclusion criteria: 1. Subjects having cystic acne. 2. Subjects with known skin condition that may impact the assessment. 3. Subject with any other signs of significant local irritation or skin disease. 4. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data. 5. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year. 6. Subjects who do not agree to remove all jewelry on/around face (e.g., necklace, earrings, if possible, nose ring), during Digital imaging. 7. Subjects having hair style which covers almost the entire forehead 8. Subjects undergoing any treatment of any skin condition on their face. 9. Subjects not willing to discontinue other topical facial products. 10. Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewelry or anything else. 11. Pregnant women (as confirmed by UPT) and lactating women 12. Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements. 13. Subjects with skin allergy history or atopic dermatitis or psoriasis. 14. Subjects who have participated in any other clinical trial in the last 3 months. 15. Subjects who were treated with Botox/filler /bio stimulatory molecules injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of the test products in reducing non cystic acne lesion count (non-inflammatory & in-flammatory lesion count) compared to baseline. 2.To evaluate the efficacy of the test products in reducing spots & pigmentation intensity compared to the baseline. 3. To assess the efficacy of test product in sebum control through Sebumeter measurement in comparison to baseline. 4. To assess the efficacy of the test product in the reduction of inflammation by dermatological and Antera based assessment in comparison to the baseline. 5.To assess the efficacy of Test product in reduction and prevention of breakouts (acne) over Treatment Phase & Regression Phase. 6.To assess the efficacy of the test product in PIH (Acne) spot lightening by Antera based assessment. 7.To study the efficacy of Test product in reduction of skin pores using Antera 3D. 8. To assess the pH of the face using pH meter Timepoint: baseline, day7, day 14, day 28, day 56, day 70 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the microflora on acne/acne prone skin compared to baseline through microbial sampling. 2.To assess the efficacy of reduction of black heads white heads, papule & pustule. 3.To assess the efficacy for overall clearer skin. 4. To assess the safety “Suitable for acne & acne prone-skinTimepoint: baseline, day7, day 14, day 28, day 56, day 70 | — |
Countries
India
Contacts
Public ContactSatyendra Kumar
MS Clinical Research Pvt Ltd
Outcome results
None listed