A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing

Bausch Health

Status

Enrolling

Conditions

Skin Resurfacing

Treatments

Device: Fraxel® FTX Laser System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07214272

FX-PAS-USA-2024-001

Details and patient eligibility

About

This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.

Full description

Study to be conducted at approximately 6 investigative sites in the United States, enrolling up to 50 male and female participants with Fitzpatrick skin types I to VI, with no more 30 (60%) participants with Fitzpatrick skin types I to III and approximately 20 (40%) participants who self-identify as being of Asian descent

Enrollment

50 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female.
21 to 60 years of age.
Written informed consent must be obtained prior to any study procedures.
Presence of one or more of the following in the treatment area(s):
1. Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
2. Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale).
3. Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale).
Ability to read, understand, and sign the informed consent form

Exclusion criteria

Pregnant, breastfeeding, or planning to become pregnant during the study.
History of any type of allergic reaction to topical anesthetics.
Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
Predisposition to keloid formation or excessive scarring.
Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study.
Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment.
Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study.
Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.
Sunburn and/or significant recent sun exposure on the target treatment zone in the last 2 weeks prior to enrollment that, according to investigator judgement, would impact treatment, and/or unwilling to practice photoprotection and/or avoid significant sun exposure for the duration of study participation.