Altreno for Chest Rejuvenation

Photoaging Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04096742
• Other study ID #: Altreno-2019-01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 6, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Goldman, Butterwick, Fitzpatrick and Groff
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Photoaging
• Photodamaged Skin

Intervention

Drug:
• tretinoin 0.05% lotion (Altreno)
Altreno topical lotion

Other:
• Vehicle
Lotion not containing active ingredient (tretinoin)

Locations

Country	Name	City	State
United States	Cosmetic Laser Dermatology/West Dermatology Research Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Goldman, Butterwick, Fitzpatrick and Groff	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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