Clinical trial NCT04096742: Altreno for Chest Rejuvenation
Official title: A Prospective, Randomized, Double-blind, Vehicle-controlled Study Evaluating the Efficacy, Safety and Patient Satisfaction of Tretinoin 0.05% Lotion (Altreno) for Chest Rejuvenation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Photodamaged Skin
Photoaging
Keywords: Skin
Chest
Photodamage
Sun Damage
Lead sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2019-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective, double-blind, randomized, vehicle-controlled study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Females or males age 18-65, Fitzpatrick skin types I-VI
2. Moderate to severe photodamage (Fitzpatrick Wrinkle score of 4-9)
3. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
4. Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
5. Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
6. Women of childbearing potential willing to use an acceptable form of birth control during trial period.

   1. Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
   2. Intrauterine coil
   3. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
   4. Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
   5. Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
7. 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:

1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
2. Known hypersensitivity or allergy to the components of the study medication.
3. Concurrent enrollment in any study involving the use of investigational devices or drugs.
4. Current smoker or history of smoking in the last five years.
5. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
6. Presence of an active systemic or local skin disease that may affect treatment area.
7. History of prior surgery to the treatment area
8. History of prior significant trauma to the chest
9. History of the following cosmetic treatments to the area(s) to be treated:

   1. Energy based device or laser procedure to the chest within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
   2. 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)
   3. Ever for permanent fillers (e.g. Silicone, ArteFill)
10. Surgical dermabrasion or chemical peels in the treatment area within the past 6 month
11. Any planned surgical intervention to the chest for the duration of the trial
12. Any visible surface alteration to the chest that may interfere with evaluation, at investigator discretion
13. Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion
14. Inability to comply with all study protocols and regulations
15. Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
16. Unwilling to minimize exposure to sunlight and sunlamps during the course of the study.

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Primary outcomes:
measure: Skin Quality
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS)
timeFrame: Baseline through Month 6
measure: Investigator Assessment-Investigator Percent Improvement Evaluation
timeFrame: 1, 3, and 6 months
measure: Investigator Assessment-Investigator Global aesthetic improvement scale (I-GAIS)
timeFrame: 1, 3, and 6 months
measure: Subject Assessments-Subject Global aesthetic improvement scale (S-GAIS)
timeFrame: 1, 3, and 6 months
measure: Subject Assessments-Patient satisfaction score
timeFrame: 1, 3, and 6 months
measure: Subject Assessments-End of study patient questionnaire
timeFrame: Month 6
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology/West Dermatology Research Center
state: California
Study officials:
affiliation: Cosmetic Laser Dermatology
name: Sabrina Fabi, MD
role: PRINCIPAL_INVESTIGATOR
References: