CTRI/2025/12/099386尚未招募不适用
A CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF A FACIAL CLEANSER IN REDUCING HYPERPIGMENTATION/POST-INFLAMMATORY HYPERPIGMENTATION (PIH) IN HEALTHY ASIAN PARTICIPANTS OVER A PERIOD OF 8 WEEKS
L’Oréal Research & Innovation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This is a monocentric, open-label, 8-week efficacy and tolerability study evaluating a facial cleanser designed for people with hyperpigmentation, conducted on Asian adults (18–55 years). A total of 60 participants will be enrolled to achieve at least 50 study completers, with at least 33% males.
Participants will use the investigational cleanser twice daily for 8 weeks and attend eight study visits: D0 (including immediate and 8-hour assessments), D3, D7, D14, D28, D42, and D56 (with allowable visit windows).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Asian male and female participants aged 18 to 55 years inclusive.
- •At least 33 percent minimum 20 participants must be male.
- •2.Male and female participants must have very light to no facial hair and agree to keep facial hair the same throughout the study.
- •No moustache or goatee allowed.
- •3.Participants must have a self perceived skin type with at least 10 percent representation of each type including normal, normal to oily, combination, and oily skin.
- •4.At least 50 percent of participants must have self perceived sensitive skin.
- •5.Participants with mild to moderate clinical grading score 3 to 6 according to a modified Griffiths scale for the whole face for Skin tone evenness Global discoloration or hyperpigmentation Global stubborn dark spots including PIH PIE as hyperpigmentation for low phototypes sunspots age spots and general dark spots Rough skin texture visual smoothness Rough skin texture tactile softness Skin clarity Brightness or radiance Enlarged pores Overall skin appearance or quality skin health 6.Participants must have at least one homogeneous well defined stubborn dark spot of at least 3 mm diameter on the face measured using a vernier caliper at screening and baseline visits.
- •7.Participants must self perceive the following concerns on the face Rough skin texture Dull skin Dark spots or hyperpigmentation Uneven skin tone Visible pores 8.Participants with Phototype II to VI as per ITA classification measured using Chromameter CR 400 on the back.
- •N 5 for phototype II and III N 25 for phototype IV N 25 for phototype V N 5 for phototype VI 9.Participants willing to avoid UV sessions sun tanning sun bathing or any extensive sun exposure during the study.
- •10.Participants agree to facial waxing or threading one to two days prior to study visits.
- •11.Participants who use makeup three to seven times a week.
- •12.Participants who have been using the same skin care and makeup products for at least one month prior to study start.
- •13.Participants who use SPF five to seven times a week.
- •14.Participants who use face wash and moisturizer one to two times a day and five to seven times a week.
- •15.Participants willing to avoid any oral or topical medications that may interfere with study results.
- •16.Participants must agree to replace their own cleanser and use only the investigational facial cleanser and the provided SPF during the study.
- •17.Participants must be using a non anti aging cleanser one to two times a day five to seven times a week.
- •19.Participants willing and able to follow study requirements instructions and schedule.
- •20.Females of childbearing potential must self declare not pregnant at screening and undergo urine pregnancy tests at Baseline Day 0 Day 28 and Day
- •21.Females of childbearing potential must either not be sexually active or must use an effective contraceptive method except systemic contraception for at least one month before the study and throughout the study.
- •Effective methods include Surgical sterilization such as oophorectomy hysterectomy or tubal ligation Oral implant or injection contraceptives Diaphragm or cervical cap with intravaginal spermicide Intravaginal device Intrauterine device Condom with spermicide.
排除标准
- •Participants with any facial permanent makeup or tanning on evaluation areas during the study period.
- •Participants who have undergone any aesthetic surgery on evaluation areas.
- •Participants with moderate to severe melasma.
- •Use of depigmenting retinol vitamin C or AHA based products on evaluation areas within one month.
- •Participants using self tanning products on evaluation areas within one month.
- •Participants using other cosmetic products on evaluation areas within 24 hours before the screening visit.
- •Participants who started hormone replacement therapy or hormonal birth control less than three months before study entry or who plan to start stop or change doses during the study.
- •Participants with any skin condition that may interfere with efficacy evaluation in the investigators opinion.
- •Participants who are pregnant lactating or planning pregnancy during the study.
- •Participants with a history of allergy or hypersensitivity to ingredients of the investigational product.
- •Participants with any significant medical condition that may interfere with study participation.
- •Participants with medical or surgical conditions or medication use that may harm them or interfere with assessments.
- •Participants using topical or systemic treatments that may interfere with the study such as corticosteroids retinoids anti inflammatory drugs or anti aging products.
- •Participants who had dermatological or anti aging procedures such as laser peel dermabrasion photo rejuvenation or facial peeling within six months before study start or during the study.
- •Participants who participated in another clinical study within one month before screening or are currently participating in another study.
- •Participants who cannot be contacted by phone in case of emergency.
研究者
Dr Pranami Kashyap
CIDP Biotech India Pvt. Ltd.
研究点 (1)
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