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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Sunscreen untinted
Other interventionParticipants will apply the facial sunscreen on the face at least twice daily for 56 days
Sunscreen tinted
Other interventionParticipants will apply the facial sunscreen on the face at least twice daily for 56 days
Treatment groups
Trial outcomes
Primary outcomes
Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
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).
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.
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.
Sponsors and contacts
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