An Exploratory Study to Evaluate Skin Brightening Effects of Different Cosmetic Formulations on UV Irradiated Tanning Model

NCT07795866 — Not applicable, Active not recruiting, 13 participants, Unilever R&D

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RegistryNCT07795866
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, other
Enrollment13 (Estimated)
SponsorUnilever R&D (Industry)
ConditionsSkin Brightening
InterventionsSMR 1, SMR 2, SMR 3, SMR 4, SMR 5, Pro-Derma 1, Pro-Derma 2, Pro-Derma 3, Pro-Derma 4, Pro-Derma 5, Thiamidol (Other)
Datesstart 2026-09-10, primary completion 2026-11-11 (estimated), completion 2026-11-11 (estimated), first posted 2026-08-31, last updated 2026-10-20
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Skin Brightening All trials of SMR 1 All trials of SMR 2

-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 .

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+Arms and interventions

ArmTypeInterventionsDescription
SMR 1Placebo comparatorOther: SMR 1
SMR 2ExperimentalOther: SMR 2
SMR 3ExperimentalOther: SMR 3
SMR 4ExperimentalOther: SMR 4
SMR 5ExperimentalOther: SMR 5
UntreatedNo intervention
Pro-Derma 1Placebo comparatorOther: Pro-Derma 1
Pro-Derma 2ExperimentalOther: Pro-Derma 2
Pro-Derma 3ExperimentalOther: Pro-Derma 3
Pro-Derma 4ExperimentalOther: Pro-Derma 4
Pro-Derma 5ExperimentalOther: Pro-Derma 5
ThiamidolActive comparatorOther: Thiamidol
  • SMR 1 (Other): Cosmetic skin brightening product to be applied to defined test site
  • SMR 2 (Other): Cosmetic skin brightening product to be applied to defined test site
  • SMR 3 (Other): Cosmetic skin brightening product to be applied to defined test site
  • SMR 4 (Other): Cosmetic skin brightening product to be applied to defined test site
  • SMR 5 (Other): Cosmetic skin brightening product to be applied to defined test site
  • Pro-Derma 1 (Other): Cosmetic skin brightening product to be applied to defined test site
  • Pro-Derma 2 (Other): Cosmetic skin brightening product to be applied to defined test site
  • Pro-Derma 3 (Other): Cosmetic skin brightening product to be applied to defined test site
  • Pro-Derma 4 (Other): Cosmetic skin brightening product to be applied to defined test site
  • Pro-Derma 5 (Other): Cosmetic skin brightening product to be applied to defined test site
  • Thiamidol (Other): Cosmetic skin brightening product to be applied to defined test site

+Outcome measures

Primary outcomes

  • L*, a*, b*, ITA [From 1-week pre-treatment phase to end of study at 8 weeks]: Measure skin color (L*, a*, b* values, calculate ITA°) on the back test areas using Spectrophotometer, CM-26d.

Secondary outcomes

  • Hydration and barrier function [From 1-week pre-treatment phase to end of study at 8 weeks]: Measure skin hydration on the back test areas using Corneometer, CM825. Measure TEWL on the back test areas using Vapometer .

Other outcomes

  • Image demo [From 1-week pre-treatment phase to end of study at 8 weeks]: Capture images on the back test areas using Antera 3D device. Capture images on the back test areas using digital camera.

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Guangzhou Landproof Testing Technology Co., Ltd.Guangzhou, GuangdongChina