Status:
RECRUITING
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Skin Resurfacing
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
Detailed 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%) participan...
Eligibility Criteria
Inclusion
- 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):
- Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
- 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).
- 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
- 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.
Key Trial Info
Start Date :
October 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07214272
Start Date
October 17 2025
End Date
September 1 2026
Last Update
January 7 2026
Active Locations (5)
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1
Dermatology Cosmetic Laser Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
La Jolla, California, United States, 92121
2
Miami Dermatology & Laser Research LLC
Miami, Florida, United States, 33133
3
Oak Dermatology, LLC
Naperville, Illinois, United States, 60563
4
Union Square Laser Dermatology, P.C
New York, New York, United States, 10003