Status:
UNKNOWN
Altreno for Chest Rejuvenation
Lead Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Photodamaged Skin
Photoaging
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 rejuven...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04096742
Start Date
August 6 2019
End Date
December 31 2021
Last Update
April 2 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cosmetic Laser Dermatology/West Dermatology Research Center
San Diego, California, United States, 92121