CTRI/2011/091/000115已完成2 期
EFFICACY AND SAFETY OF SKIN LIGHTENING TOPICALCREAM IN DARK SPOTS
PIERRE FABRE DERMOCOSMETIQUE0 个研究点目标入组 90 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
- 90
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. Female aged between 18 and 50 years,
- •2. Subjects with phototypes III to VI,
- •3. Subjects with epidermal melasma of the face (bilateral hyperpigmented spots) graded moderate to severe (Grade 2 and 3 of the Static PGA)
- •4. For women of child bearing potential:
- •- negative urine pregnancy test at inclusion
- •- using an efficient contraceptive (condoms, implants, combined oral contraceptives, some intra-uterine devices, tubal ligature, sexual abstinence or vasectomised partner related to note 3 of the CPMP/ICH/286/95) for at least 8 weeks before the study and one month after the end of the study or using an oral contraceptive with more than 30μg of ethinyl-estradiol or progestative one, it having to be started since more than 12 weeks and until the end of the study.
- •5. Subject accepting to participate to the study and able to understand (linguistic and psychiatric),date and sign an approved Informed Consent Form and able to complete the subject diary
- •6. Subject able to understand the protocol and to come to the evaluation visits,
- •7. Subject who, in the judgement of the investigator is likely to be compliant during the study
- •8. Subject agreeing to use for epidermal melasma only the study products and no other treatment(s)/product(s)during the study duration
排除标准
- •Subjects with dark spots on their face other than epidermal melasma, (as there will be difficulty in
- •standardization and difficulty in evaluation due to lack of standard assessment tools and questionnaires for
- •these dark spots).
- •? Subjects with dermal melasma
- •? Subject with other skin disorder on the face which could interfere with the evaluation (mycose, intertrigo),
- •? Acute or chronic systemic disease or disorder liable to interfere with the study product metabolism and/or
- •study implementation and/or study parameter assessment.
- •? Treatment by depigmenting cosmetic products applied to the face within the previous 4 weeks,
- •? Treatment by depigmenting treatment containing hydroquinone or any depigmenting product (e.g. topical
- •retinoids, topical steroids, ?) applied to the face within the previous 8 weeks,
- •? Previous treatment by chemical peels, laser treatments, dermabrasions, applied to the face with in previous 3
- •? Hypersensitivity, allergy or intolerance to hydroquinone or any component of the formulation,
- •Treatment by photosensitive agents within the previous 8 weeks,
- •? Subject who has planned to stay for more than 7 days in an area with an important increase in sun exposure
- •conditions compared to her usual place of residence during the study,
- •? Female who is pregnant or breast feeding or planning to become pregnant,
- •? Participation to an other clinical trial in the previous month or during the study,
- •? Past history of major medical, psychiatric disease or surgery which, in the judgment of the investigator , could
- •jeopardize their health or likely to modify their handling of the study product
- •? Subject who, in the judgement of the investigator, is not likely to be non-compliant during the study,
- •? Subject who has forfeited her freedom by administrative or legal decision, or who is under guardianship.
研究者
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