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

NCT07679945 | Recruiting

• 1 other identifier: CS2026SK100350
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-inflammatory Hyperpigmentation; Melasma; Solar Lentigo

Outcome Measures

Primary Outcomes (7)

• Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation

  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)

  Measurements will be taken using the Chroma Meter® CR 400 to evaluate the color intensity of the dark spot (Melasma, Solar Lentigo, or Post-Inflammatory Hyperpigmentation) in comparison to the measurement of an adjacent area (without a spot).

  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.)

  Facial images will be captured using the Visia CR® Facial Imaging Booth (Canfield Scientific, Inc.) for analysis of the intensity and size of the spot (Melasma, Solar Spot, or Post-Inflammatory Hyperpigmentation), as well as the overall uniformity of skin tone.

  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)

  Melasma Quality of Life Scale (MELASQoL) will only be answered by participants enrolled in Melasma group. The participant will answer a questionnaire with 10 questions regarding the condition of their skin, using a rating scale from 1 to 7, in which: 1 means "not at all bothered" and 7 means "bothered all the time". A total score will be generated by summing the scores of the 10 questions answered by the participant. The total score ranges from 10 to 70. The lower the score, the better the participant's quality of life.

  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)

  Dermatology Life Quality Index (DLQI) will only be answered by participants selected for the Solar Lentigo/PIH Group. The participant will answer a questionnaire with 10 questions regarding the impact of their skin on their quality of life. Each question is scored on a four-point Likert scale: very much = 3 points, much = 2 points, a little = 1 point and nothing/not relevant = 0 points. Questions answered as nothing and not relevant are equivalent to 0 points. The total score ranges from 0 to 30. The lower the score, the better the participant's quality of life.

  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

  Participants will answer a questionnaire evaluating their individual opinion about the Investigational Product used. Questionnaire consists of 9 questions which should be answered in a 5-point scale of agreement (such as ranging from "Strongly Disagree" to "Strongly Agree").

  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

  Consists of an open-ended, narrative question in which the participant provides a brief statement regarding their experience with the use of their respective Investigational Product.

  After Visit 4 (56+2 days) of IP use

Study Arms (4)

Group I: Melasma/Untinted

EXPERIMENTAL

Other: Sunscreen untinted

Group I: Melasma/Tinted

EXPERIMENTAL

Other: Sunscreen tinted

Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted

EXPERIMENTAL

Other: Sunscreen untinted

Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted

EXPERIMENTAL

Other: Sunscreen tinted

Interventions

Sunscreen untinted OTHER

Participants will apply the facial sunscreen on the face at least twice daily for 56 days

Group I: Melasma/Untinted; Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted

Sunscreen tinted OTHER

Participants will apply the facial sunscreen on the face at least twice daily for 56 days

Group I: Melasma/Tinted; Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenvue Brands LLC: lead

Study Sites (1)

ALS Beauty & Personal Care Ltda

Campinas, São Paulo, 13084-791, Brazil

RECRUITING

MeSH Terms

Conditions

Hyperpigmentation; Melanosis

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Kenvue Global Clinical Operations

CONTACT

18779295131; KenvueClinical_KV@kenvue.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: July 1, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06-23

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)