UnknownPhase 4

Altreno for Chest Rejuvenation

United States40 participantsStarted 2019-08-06

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Skin Quality

Timeframe: Baseline through Month 6

Trial details

NCT IDNCT04096742

SponsorGoldman, Butterwick, Fitzpatrick and Groff

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-30

View on ClinicalTrials.gov More Photodamaged Skin trials