Altreno for Chest Rejuvenation

NCT ID: NCT04096742

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2021-12-31

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.

Conditions

Photodamaged Skin; Photoaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Altreno

tretinoin 0.05% lotion (Altreno)

Group Type: EXPERIMENTAL

tretinoin 0.05% lotion (Altreno)

Intervention Type: DRUG

Altreno topical lotion

Vehicle

Vehicle lotion not containing tretinoin

Group Type: SHAM_COMPARATOR

Vehicle

Intervention Type: OTHER

Lotion not containing active ingredient (tretinoin)

Interventions

tretinoin 0.05% lotion (Altreno)

Altreno topical lotion

Intervention Type: DRUG

Vehicle

Lotion not containing active ingredient (tretinoin)

Intervention Type: OTHER

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Goldman, Butterwick, Fitzpatrick and Groff

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabrina Fabi, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmetic Laser Dermatology

Locations

Cosmetic Laser Dermatology/West Dermatology Research Center

San Diego, California, United States

Countries

United States

Other Identifiers

Altreno-2019-01

Identifier Type: -

Identifier Source: org_study_id