Altreno for Chest Rejuvenation

Phase 4

• Conditions: Photodamaged Skin; Photoaging
• Interventions: Drug: tretinoin 0.05% lotion (Altreno); Other: Vehicle

• Registration Number: NCT04096742
• Lead Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-06
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-01
• Last Update Posted: 2021-04-02
• Primary Completion: 2021-07-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Altreno	tretinoin 0.05% lotion (Altreno)	tretinoin 0.05% lotion (Altreno)
Vehicle	Vehicle	Vehicle lotion not containing tretinoin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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-End of study patient questionnaire	Month 6	End of study patient questionnaire
Subject Assessments-Patient satisfaction score	1, 3, and 6 months	Patient satisfaction score

Trial Locations

Locations (1)

Cosmetic Laser Dermatology/West Dermatology Research Center; 🇺🇸 San Diego, California, United States