Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms

Korábbi kezelés

• Patients with dark hair in the treatment area who are unwilling to shave the treated area prior to IPL treatments or who are unwilling to proceed knowing IPL will eliminate at least 50% of the hairs in the treatment area
• A suntan in the treatment area or use of sunless tanner/spray-tan in the treatment areas 4 weeks prior to study treatment
• Use of at-home energy-based devices intended for rejuvenation or fibroblastic/collagen stimulation on the treatment area within 30 days prior to treatment and during the study period.
• Use of GLP-1 medications or metformin within 3 months prior to enrollment
• Current or recent use (within the past 3 months) of systemic immunosuppressive medications.
• Active smoking tobacco or use of nicotine-containing products within 6 months prior to enrollment.
• Participation in any other interventional clinical study within 30 days prior to enrollment or during the course of this study.

Más betegség

• Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
• History of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma, dermatomyositis).
• Any uncontrolled systemic condition that may increase risk or interfere with study participation, including but not limited to poorly managed diabetes, thyroid dysfunction, or cardiovascular disease.
• Clinically significant neurological, psychological or psychiatric conditions, or any condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results.
• History of keloids or scarring/tattoos in the treatment area

Egyéb

• Pregnancy, plans to become pregnant during the study period, or current breastfeeding.
• Unwillingness to refrain from undergoing any additional aesthetic treatments to the arms (e.g., lasers, injectables, energy-based devices, cosmeceuticals, etc.) from screening through the end of the study period.

• Female participants aged 50 to 80 years.
• Fitzpatrick skin types I-IV.
• Moderate to severe photodamage and crepiness on the arms, based on clinical evaluation, including fine wrinkling, coarse wrinkling, photodamage, and a global assessment as assessed with the 10-point Dermatologic Assessment Form and Photographic Scale
• Willing and able to comply with all study requirements, including scheduled visits, treatment protocol, and follow-up assessments.
• Willing to sign an informed consent form and photography release for research, publication, and/or commercial use.
• In good general health as determined by the investigator based on medical history and clinical judgment.
• Willing to maintain the study skincare regimen and refrain from introducing new topical or procedural treatments to the forearms during the study period.
• Negative urine pregnancy test at all visits for participants of childbearing potential.
• Participants must be of non-childbearing potential, defined as: a. History of hysterectomy or bilateral oophorectomy, or b. No menses for at least 12 consecutive months without an alternative medical cause. Or, if of childbearing potential, must agree to use an effective form of contraception during the course of the study. Acceptable methods include: i. Oral contraceptive pill, injection, implant, patch, vaginal ring, or intrauterine device (IUD) ii. Intrauterine coil iii. Bilateral tubal ligation iv. Hysterectomy v. Barrier method used with an additional form of contraception (e.g., spermicide, sponge, or condom) vi. Abstinence (must agree to use a barrier method if sexual activity begins during the study) vii. Partner with a vasectomy (if not, participant must agree to use a barrier method)