Investigating the Safety and Effectiveness of TLS-SA23 on Healthy Females
- Registration Number
- CTRI/2023/08/056456
- Lead Sponsor
- Transformative Learning Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method