Altreno for Chest Rejuvenation
Study Details
Study Description
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 rejuvenation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Altreno tretinoin 0.05% lotion (Altreno) |
Drug: tretinoin 0.05% lotion (Altreno)
Altreno topical lotion
|
| Sham Comparator: Vehicle Vehicle lotion not containing tretinoin |
Other: Vehicle
Lotion not containing active ingredient (tretinoin)
|
Outcome Measures
Primary Outcome Measures
- Skin Quality [Baseline through Month 6]
Nine-point scale to assess skin quality for the appearance of crepiness, coarse lines/wrinkles, skin texture, and skin tone evenness
Secondary Outcome Measures
- Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS) [Baseline through Month 6]
Fabi-Bolton Wrinkle Scale (FBWS)
- Investigator Assessment-Investigator Percent Improvement Evaluation [1, 3, and 6 months]
Investigator Percent Improvement Evaluation
- Investigator Assessment-Investigator Global aesthetic improvement scale (I-GAIS) [1, 3, and 6 months]
Investigator Global aesthetic improvement scale (I-GAIS)
- Subject Assessments-Subject Global aesthetic improvement scale (S-GAIS) [1, 3, and 6 months]
Subject Global aesthetic improvement scale (S-GAIS)
- Subject Assessments-Patient satisfaction score [1, 3, and 6 months]
Patient satisfaction score
- Subject Assessments-End of study patient questionnaire [Month 6]
End of study patient questionnaire
Eligibility Criteria
Criteria
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.
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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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cosmetic Laser Dermatology/West Dermatology Research Center | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Goldman, Butterwick, Fitzpatrick and Groff
- Bausch Health Americas, Inc.
Investigators
- Principal Investigator: Sabrina Fabi, MD, Cosmetic Laser Dermatology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Altreno-2019-01