A Phase 4, Single-Site Study Assessing Improvement of Skin Discoloration and Texture With Combination Treatment of Novel Moisturizer and Non-Ablative Laser Treatment Inclusive of Fitzpatrick Skin Types I-VI and Asian Descent

PDCR-000297

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.

2023-12-01

2024-06-01

2024-07-01

Not yet recruiting

Early phase I

40

Inclusion Criteria: 1. Healthy female subjects aged between 25 and 70 years, all skin types included 2. Symmetrical photoaging 3. No known medical conditions that, in the Investigator's opinion may interfere with study participation 4. Willingness to cooperate and participate by following study requirements 5. Female subjects of childbearing potential must be willing to use appropriate contraception method(s) 6. Individuals must sign an informed consent and a photography consent Exclusion Criteria: 1. Subjects that are being treated for cancer or have a history of facial skin cancer on the test areas 2. 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 3. 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 4. 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 5. Women known to be pregnant, nursing or planning to become pregnant 6. Subjects participating in other facial clinical studies 7. 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. 8. Subjects who have used Retinol in the last 4 weeks 9. Subjects with current flaring severe inflammatory acne 10. Subjects who have had ablative laser treatments, microneedling, and/or chemical peels or dermabrasion within the last six months 11. Subjects who have had botulinum type-A toxin (e.g. Botox®, Daxxify®, Dysport®, Jeaveau®, or Xeomin®) within the last 6 months 12. Subjects who have had dermal filler injections within the last 12 months 13. Subjects who have had non-ablative laser treatments or IPL within the last 3 months 14. Subjects with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs 15. Subjects currently using topically applied prescription medications on the face

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-Face study design. Phyto A+ Brightening Treatment and placebo moisturizer will be randomized regardless of Fitzpatrick Skin Type (FST). Subjects will be assigned to a laser treatment based on their Fitzpatrick Skin Type, as determined by the Investigator. Subjects with FST I-III will receive the Sciton laser procedure. Subjects with FST IV-VI will receive LaseMD laser procedure. Half of the face will be treated with Phyto A+ Brightening Treatment and assigned laser treatment. The other half of the face will be treated with placebo moisturizer and assigned laser treatment.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Phyto A+ Brightening Treatment and placebo moisturizer will be labeled as Study Product A or Study Product B. Subjects, delegated site staff, or investigators will not know which product is applied to either side of the face.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-10-27