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

Goldman, Butterwick, Fitzpatrick and Groff1 site in 1 country40 target enrollmentAugust 6, 2019

ConditionsPhotodamaged Skin Photoaging

Interventionstretinoin 0.05% lotion (Altreno)Vehicle

Drugstretinoin 0.05% lotion (Altreno)

Overview

Phase: Phase 4
Intervention: tretinoin 0.05% lotion (Altreno)
Conditions: Photodamaged Skin
Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Enrollment: 40
Locations: 1
Primary Endpoint: Skin Quality
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 6, 2019

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Goldman, Butterwick, Fitzpatrick and Groff

Responsible Party

Sponsor

Eligibility 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.
•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).

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)

Arms & Interventions

Altreno

tretinoin 0.05% lotion (Altreno)

Intervention: tretinoin 0.05% lotion (Altreno)

Vehicle

Vehicle lotion not containing tretinoin

Intervention: Vehicle

Outcomes

Primary Outcomes

Skin Quality

Time Frame: 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 Outcomes

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