Active — Not RecruitingNot Applicable

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

United States49 participantsStarted 2025-10-17

Plain-language summary

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

Age range21 Years – 60 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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.

Primary Endpoint

Timeframe: 26 weeks

NCT IDNCT07214272

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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.