Altreno for Chest Rejuvenation

NCT04096742 | Unknown Phase 4 FDA Drug

• 1 other identifier: Altreno-2019-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Skin; Chest; Photodamage; Sun Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS)

  Baseline through Month 6

• Investigator Assessment-Investigator Percent Improvement Evaluation

  1, 3, and 6 months

• 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-Patient satisfaction score

  1, 3, and 6 months

Study Arms (2)

Altreno

EXPERIMENTAL

tretinoin 0.05% lotion (Altreno)

Drug: tretinoin 0.05% lotion (Altreno)

Vehicle

SHAM COMPARATOR

Vehicle lotion not containing tretinoin

Other: Vehicle

Interventions

tretinoin 0.05% lotion (Altreno) DRUG

Altreno topical lotion

Altreno

Vehicle OTHER

Lotion not containing active ingredient (tretinoin)

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
• 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.

You may not qualify if:

• 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)
• 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)
• Ever for permanent fillers (e.g. Silicone, ArteFill)
• Surgical dermabrasion or chemical peels in the treatment area within the past 6 month
• Any planned surgical intervention to the chest for the duration of the trial
• Any visible surface alteration to the chest that may interfere with evaluation, at investigator discretion

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Cosmetic Laser Dermatology/West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Interventions

Tretinoin

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Sabrina Fabi, MD

  Cosmetic Laser Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, prospective, double-blind, randomized, vehicle-controlled study

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: August 6, 2019
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)