A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing

Study to be conducted at approximately 6 investigative sites in the United States, enrolling up to 50 male and female participants with Fitzpatrick skin types I to VI, with no more 30 (60%) participants with Fitzpatrick skin types I to III and approximately 20 (40%) participants who self-identify as being of Asian descent

Inclusion criteria

• Male or female.
• 21 to 60 years of age.
• Written informed consent must be obtained prior to any study procedures.
• Presence of one or more of the following in the treatment area(s):

• Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
• Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale).
• Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale).
• Ability to read, understand, and sign the informed consent form

Exclusion criteria

• Pregnant, breastfeeding, or planning to become pregnant during the study.
• History of any type of allergic reaction to topical anesthetics.
• Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
• Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
• Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
• Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
• Predisposition to keloid formation or excessive scarring.
• Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
• Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
• Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study.
• Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
• Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
• Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment.
• Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study.
• Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.
• Sunburn and/or significant recent sun exposure on the target treatment zone in the last 2 weeks prior to enrollment that, according to investigator judgement, would impact treatment, and/or unwilling to practice photoprotection and/or avoid significant sun exposure for the duration of study participation.