Trial Evaluating Both Tolerability and Improvement for Signs of Facial Photoaging, Discoloration,… (NCT06090071) | Clinical Trial Compass
CompletedPhase 4
Trial Evaluating Both Tolerability and Improvement for Signs of Facial Photoaging, Discoloration, and Texture in Adult Females of All Skin Types by Combining a Placebo Moisturizer and Non-ablative Laser.
United States38 participantsStarted 2023-11-14
Plain-language summary
This is a phase 4 trial evaluating the clinical effect of combining a placebo moisturizer and non-ablative laser to improve procedural outcomes in patients with facial dyschromia. This study's objective is to evaluate both the tolerability and improvement in signs of photoaging for a placebo moisturizer used in combination with a non-ablative laser. Physician assessments, patient reported outcomes, and digital photos will be captured.
Who can participate
Age range25 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Healthy female subjects aged between 25 and 70 years, all skin types included
✓. Symmetrical photoaging
✓. No known medical conditions that, in the Investigator's opinion may interfere with study participation
✓. Willingness to cooperate and participate by following study requirements
✓. Female subjects of childbearing potential must be willing to use appropriate contraception method(s)
✓. Individuals must sign an informed consent and a photography consent
Exclusion criteria
✕. Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas
✕. Subjects with sunburn, moderate to pronounced suntan, pronounced asymmetric skin aging, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might include the test results
✕. Subjects currently taking certain medications which in the opinion of the Investigator(s) may interfere with the study. This includes but is not limited to routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids \[steroid nose drops, inhalers and/or eye drops are permitted\]), and immunosuppessive drugs
✕. Subjects with self-reported, uncontrolled systemic disease which, in the opinion of the Investigator, may hinder either the subject's ability to perform all responsibilities of the trial or the Investigator's ability to perform assessments
✕. Women known to be pregnant, nursing or planning to become pregnant
✕. Subjects participating in other facial clinical studies
✕. Subjects who have routinely used an alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid (BHA) containing product within two weeks or Retin-A, Retin-A Micro, Renova, Differin, Avita, Tazorac, or Soriatane within 8 weeks of the study start or have taken Isotretinoin within one year of the study start.
✕. Subjects who have used Retinol in the last 4 weeks