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NCT07795866
An Exploratory Study to Evaluate Skin Brightening Effects of Different Cosmetic Formulations on UV Irradiated Tanning Model
Conditions: Skin Brightening
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 13
Sponsor: Unilever R&D
Location: Guangzhou Landproof Testing Technology Co., Ltd. Guangzhou Guangdong
Summary
This is a double-blind randomized, complete block design study on Chinese population, expecting approximately 18 participants recruited and at least 10 participants to complete the whole 9-week study. The study test sites will receive a single 2MED UV radiation .
Eligibility Criteria
Inclusion Criteria:
* Healthy Chinese female or male, aged from 18 to 50 years old (both inclusive).
* Participants in good health condition as per the health history questionnaire with no disease state or physical condition that the investigator believes could interfere with the interpretation of the data.
* Participant is able to read, understand and sign an appropriate informed consent form indicating his willingness to participate.
* ITA° range 10-42°; Skin type III and IV included and can tolerance 2MED radiation.
* No history of allergic diseases or allergies to cosmetics, UV light and other topical preparations.
* No history of photosensitive diseases and no recent use of medications that affect photosensitivity.
* The test area skin (back) should be free of birthmarks, inflammation, scars, excessive hair, etc.
* No cuts, abrasions, fissures, wounds, lacerations on the test site (back).
* Participants must understand the trial process, voluntarily participate in the study, and sign a written informed consent form.
* Willing to attend the study center twice daily for product application during the study period and complete all visits.
Exclusion Criteria:
* Study participants are employees of Sponsor or CRO.
* The study participants participated in test involving the test site within 2 months prior to the start of this test or are currently participating in such tests.
* Study participants had any other visible signs of local irritation, erythema, or skin disease on the visible parts of the body.
* Study participants consider they are prone to breakouts and/or sensitive skin.
* Study participants had a chronic illness or had major surgery in the past year.
* Study participants were receiving any skin treatments on the test sites.
* Study participants had allergies or sensitivities to cleansing products, creams/emulsion, costume jewelry, or other things.
* Female study participants were pregnant/breastfeeding or planning to become pregnant during the trial (study participants self-declared at screening visits).
* Study participants took medication for any condition, which the researchers believe may have affected the interpretation of the data.
* Study participants had a history of psoriasis, eczema, atopic dermatitis, severe acne, etc. Or have other chronic systemic diseases.
* Study participants had received oral or topical corticosteroids and other anti-inflammatory drugs within the last 1 month.
* Study participants used tartaric acid, salicylic acid and any other products or drugs that affect skin colour (such as hydroquinones) within the last 2 months.
* Study participants used retinoic acid preparations or aesthetic treatment such as chemical stripping, laser, pulsed light, etc. in the test site in the past three months.
* Study participants were inevitably exposed to prolonged sunlight.
* Clinical evaluation considers that participants are not suitable for the test.
Source: ClinicalTrials.gov (NCT07795866). StuddyBuddy aggregates publicly available trial information.