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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKenvue Brands LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to understand and follow study instructions

Fitzpatrick skin types I-VI

Mild to moderate melasma, or

Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sunscreen untinted

    Other intervention

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

  • Sunscreen tinted

    Other intervention

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

Treatment groups

152 Participants
are divided into 4 treatment groups
Group A: Group I: Melasma/UntintedExperimental treatment 1 intervention
Group B: Group I: Melasma/TintedExperimental treatment 1 intervention
Group C: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / UntintedExperimental treatment 1 intervention
Group D: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / TintedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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).

Time frame
Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
3

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.

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
4

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.

Time frame
Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

Secondary outcomes

Other outcomes

Sponsors and contacts

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