Altreno for Chest Rejuvenation

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Double-blind, Vehicle-controlled Study Evaluating the Efficacy, Safety and Patient Satisfaction of Tretinoin 0.05% Lotion (Altreno) for Chest Rejuvenation.

Conditions
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Photodamaged Skin, Photoaging

Intervention / Treatment
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* Drug: tretinoin 0.05% lotion (Altreno)
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-center, prospective, double-blind, randomized, vehicle-controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Altreno<br>tretinoin 0.05% lotion (Altreno) | Drug: tretinoin 0.05% lotion (Altreno)<br>* Altreno topical lotion<br>|
| Sham Comparator: Vehicle<br>Vehicle lotion not containing tretinoin | Other: Vehicle<br>* Lotion not containing active ingredient (tretinoin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Quality | Nine-point scale to assess skin quality for the appearance of crepiness, coarse lines/wrinkles, skin texture, and skin tone evenness | Baseline through Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS) | Fabi-Bolton Wrinkle Scale (FBWS) | Baseline through Month 6 | 
| Investigator Assessment-Investigator Percent Improvement Evaluation | Investigator Percent Improvement Evaluation | 1, 3, and 6 months | 
| Investigator Assessment-Investigator Global aesthetic improvement scale (I-GAIS) | Investigator Global aesthetic improvement scale (I-GAIS) | 1, 3, and 6 months | 
| Subject Assessments-Subject Global aesthetic improvement scale (S-GAIS) | Subject Global aesthetic improvement scale (S-GAIS) | 1, 3, and 6 months | 
| Subject Assessments-Patient satisfaction score | Patient satisfaction score | 1, 3, and 6 months | 
| Subject Assessments-End of study patient questionnaire | End of study patient questionnaire | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, Chest, Photodamage, Sun Damage