study to evaluate the Skin Brightening Effects of New Liftactiv B3 Melasyl Serum on Acne Marks for 3 Months
- Registration Number
- CTRI/2023/10/058831
- Lead Sponsor
- VICHY LABORATOIRES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
1. Subjects with various skin types, including normal, dry, oily, and combination,
2. 50% of the subjects with self-declared sensitive skin
3. Subjects with phototype III to VI (where all phototype will be enrolled in equal proportion for both the groups).
4. Subjects with at least 2 epidermal spots that can be measured no dermal pigmentation as confirmed by Dermascopy/ wood’s lamp.
5. Subjects with a minimum hair length of 10-15 cm.
6. Subjects having mild active acne (less than 10 retentional and 5 inflammatory lesions).
7. Subjects with mild to moderate facial post acne hyperpigmentation.
8. Subjects who agree not to change their lifestyle during the study period.
9. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
10. Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
11. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
12. 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).
13. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
14. Subjects willing to abide by and comply with the study protocol
1.Subjects suffering from severe acne.
2.Subjects under topical or systemic retinoids.
3.Subjec.ts under systemic immunosuppressants
4. Subjects under active treatment of PIHP (including topicals or procedures) within the last 3 months.
5. Subjects treated with facial procedures within the last 3 months
6. Subjects diagnosed with Dermal melanosis by Dermascope
7. Subjects diagnosed with Lichen Planus Pigmentosus.
8. Subject with any other signs of significant local irritation or skin disease.
9. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
10. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
11. Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA CR imaging.
12. Subjects having hair style which covers almost the entire forehead
13. Subjects undergoing any treatment of any skin condition on their face
14. Subjects not willing to discontinue other topical facial products.
15. Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
16. Subjects who are pregnant and lactating
17. Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
18. Subjects with skin allergy, history of atopic dermatitis or psoriasis
19. Subjects who have participated in any other clinical trial in the last 3 months.
20. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
21. Subjects who have undergone treatment with Botox/filler /bio stimulatory molecules injection.
22. Subjects not able to provide Informed Consent and comply with the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate and compare the efficacy of the test products in improving the PAHPI score in 12 weeks compared to the baselineTimepoint: baseline, Month1 , Month2, Month3
- Secondary Outcome Measures
Name Time Method 1. To evaluate and compare the effectiveness of the test products in improving IGA scores.Timepoint: baseline, Month1 , Month2, Month3