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Recruiting NCT07679945

A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants

No phase Interventional Post-inflammatory Hyperpigmentation Melasma Solar Lentigo

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sunscreen untinted, Sunscreen tinted.
Who it may be relevant to
Registry conditions: Post-inflammatory Hyperpigmentation, Melasma, Solar Lentigo. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants

Overview

The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.

Interventions

  • Other Sunscreen untinted
    Participants will apply the facial sunscreen on the face at least twice daily for 56 days
  • Other Sunscreen tinted
    Participants will apply the facial sunscreen on the face at least twice daily for 56 days

Primary outcome measures

  • Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation [Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use]
  • Instrumental measurements with the Chroma Meter CR 400 (Konica Minolta) [Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use]
  • Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.) [Time frame: Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use]
  • Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL) [Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use]
  • Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI) [Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use]
  • Perceived efficacy assessed through perception questionnaires completed by the research participants [Time frame: After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use]
  • Open emotional testimonial written by the participant at the end of IP use [Time frame: After Visit 4 (56+2 days) of IP use]

Eligibility criteria

Inclusion criteria

  • Able to understand and follow study instructions
  • Fitzpatrick skin types I-VI
  • Presence of facial hyperpigmentation, such as:
  • Mild to moderate melasma, or
  • Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
  • Willing to comply with study procedures and product use
  • For subjects in applicable groups: willing to use assigned sunscreen product

Exclusion criteria

  • Known sensitivity or allergy to cosmetic or skincare products
  • Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
  • Use of medications or products that may interfere with study evaluations
  • Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
  • Excessive sun exposure or use of tanning beds immediately prior to or during the study
  • Pregnancy or intention to become pregnant during the study
  • Participation in another clinical study within a recent period
  • Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • ALS Beauty & Personal Care Ltda — Campinas

Identifiers

NCT: NCT07679945 · CS2026SK100350

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗