NCT07795866

Brief 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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2026

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • L*, a*, b*, ITA

    Measure skin color (L\*, a\*, b\* values, calculate ITA°) on the back test areas using Spectrophotometer, CM-26d.

    From 1-week pre-treatment phase to end of study at 8 weeks

Secondary Outcomes (1)

  • Hydration and barrier function

    From 1-week pre-treatment phase to end of study at 8 weeks

Other Outcomes (1)

  • Image demo

    From 1-week pre-treatment phase to end of study at 8 weeks

Study Arms (12)

SMR 1

PLACEBO COMPARATOR
Other: SMR 1

SMR 2

EXPERIMENTAL
Other: SMR 2

SMR 3

EXPERIMENTAL
Other: SMR 3

SMR 4

EXPERIMENTAL
Other: SMR 4

SMR 5

EXPERIMENTAL
Other: SMR 5

Untreated

NO INTERVENTION

Pro-Derma 1

PLACEBO COMPARATOR
Other: Pro-Derma 1

Pro-Derma 2

EXPERIMENTAL
Other: Pro-Derma 2

Pro-Derma 3

EXPERIMENTAL
Other: Pro-Derma 3

Pro-Derma 4

EXPERIMENTAL
Other: Pro-Derma 4

Pro-Derma 5

EXPERIMENTAL
Other: Pro-Derma 5

Thiamidol

ACTIVE COMPARATOR
Other: Thiamidol

Interventions

SMR 1OTHER

Cosmetic skin brightening product to be applied to defined test site

SMR 1
SMR 2OTHER

Cosmetic skin brightening product to be applied to defined test site

SMR 2
SMR 3OTHER

Cosmetic skin brightening product to be applied to defined test site

SMR 3
SMR 4OTHER

Cosmetic skin brightening product to be applied to defined test site

SMR 4
SMR 5OTHER

Cosmetic skin brightening product to be applied to defined test site

SMR 5

Cosmetic skin brightening product to be applied to defined test site

Pro-Derma 1

Cosmetic skin brightening product to be applied to defined test site

Pro-Derma 2

Cosmetic skin brightening product to be applied to defined test site

Pro-Derma 3

Cosmetic skin brightening product to be applied to defined test site

Pro-Derma 4

Cosmetic skin brightening product to be applied to defined test site

Pro-Derma 5

Cosmetic skin brightening product to be applied to defined test site

Thiamidol

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

SMR 2thiamidol

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

November 11, 2026

Study Completion (Estimated)

November 11, 2026

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share