Altreno for Chest Rejuvenation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Photoaging; Photodamaged Skin
• Intervention / Treatment: Drug: tretinoin 0.05% lotion (Altreno); Other: Vehicle

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology/West Dermatology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: Sabrina Fabi, MD, Cosmetic Laser Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Skin; Photodamage; Chest; Sun Damage
• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: Altreno-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No