CTRI/2023/10/058831已完成2 期
Evaluation of the depigmenting effect of New Liftactiv B3 Melasyl serum (full-face) in patients with mild to moderate facial post-acne PIHP for 3 months. - NI
VICHY LABORATOIRES0 个研究点目标入组 112 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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