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

Официальное название

A Randomized, Double-Blind, Vehicle-Controlled, Split-Arm Study of Twice Daily Re-Q Pro-Longevity Serum in Combination With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms

Обзор

The primary objective is to compare Re-Q Pro-Longevity serum versus vehicle serum combined with Intense Pulsed Laser for the treatment of moderate to severe photodamage and crepiness on the dorsal forearms.

Подробное описание

This is a randomized, double-blind, split-arm study consisting of twenty (20) adult participants with moderate to severe photodamage and crepiness on the dorsal forearms. Participants who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled. Respective arms will be randomized to receive 2 weeks of pre-treatment either with Re-Q Pro-Longevity Serum on one arm and vehicle serum on the other arm. Participants will apply the study product to the bilateral dorsal forearms after facial cleansing every morning and evening. The participants will return back to the site at week 2 (days 0) for second visit. Participants will receive first IPL treatment from the dorsal hands to the elbows.

Вмешательства

• Препарат Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy
  Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy
• Препарат Left Arm treated with vehicle serum and Intense Pulsed Light Therapy
  Left Arm treated with vehicle serum and Intense Pulsed Light Therapy

Первичные конечные точки

• Physician Global Aesthetic Improvement Scale (PGAIS): [Срок оценки: Day 84 (Week 14 Post Second Treatment)]

Вторичные конечные точки (3)

• Participant Global Aesthetic Improvement Scale (SGAIS): [Срок оценки: Day 84 (Week 14 Post Second Treatment)]
• 10-point Dermatologic Assessment Form and Photographic Scale [Срок оценки: Screening and Day 84 (Week 14 Post Second Treatment)]
• Skin Quality Assessment [Срок оценки: Screening and Day 84 (Week 14 Post Second Treatment)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
• 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
• Pregnancy, plans to become pregnant during the study period, or current breastfeeding.
• History of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma, dermatomyositis).
• Current or recent use (within the past 3 months) of systemic immunosuppressive medications.
• 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.
• 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.
• 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.
• History of keloids or scarring/tattoos in the treatment area

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Dermatology Research Center/Cosmetic Laser Dermatology — San Diego

Идентификаторы

NCT: NCT07686198 · IIT-Rapalogix-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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