Altreno for Chest Rejuvenation

Status unconfirmed · Phase 4

Conditions studied: Photodamaged Skin, Photoaging

In brief

This is a single-center, prospective, double-blind, randomized, vehicle-controlled study to evaluate the efficacy, safety and patient satisfaction of tretinoin 0.05% lotion (Altreno) for chest rejuvenation.

Key facts

Study ID

NCT04096742

Run by

Goldman, Butterwick, Fitzpatrick and Groff

People needed

40

Starts

2019-08-06

Expected to finish

2021-12-31

Last updated by the study team

2021-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females or males age 18-65, Fitzpatrick skin types I-VI
• Moderate to severe photodamage (Fitzpatrick Wrinkle score of 4-9)
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
• Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
• Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
• Women of childbearing potential willing to use an acceptable form of birth control during trial period.
• Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
• Intrauterine coil
• Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
• Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
• Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
• Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.

You may not qualify if…

• Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
• Known hypersensitivity or allergy to the components of the study medication.
• Concurrent enrollment in any study involving the use of investigational devices or drugs.
• Current smoker or history of smoking in the last five years.
• Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
• Presence of an active systemic or local skin disease that may affect treatment area.
• History of prior surgery to the treatment area
• History of prior significant trauma to the chest
• History of the following cosmetic treatments to the area(s) to be treated:
• Energy based device or laser procedure to the chest within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
• Injectable filler of any type to the chest in the past 2 years (Hyaluronic acid fillers (Voluma, Belotero), Poly-L-Lactic acid fillers (e.g. Sculptra), and CaHA fillers (e.g. Radiesse)
• Ever for permanent fillers (e.g. Silicone, ArteFill)
• Surgical dermabrasion or chemical peels in the treatment area within the past 6 month
• Any planned surgical intervention to the chest for the duration of the trial
• Any visible surface alteration to the chest that may interfere with evaluation, at investigator discretion
• Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion
• Inability to comply with all study protocols and regulations
• Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
• Unwilling to minimize exposure to sunlight and sunlamps during the course of the study.

Where it is running

• Cosmetic Laser Dermatology/West Dermatology Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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