Phase 2
N=15
Fractional Resurfacing Device for Treatment of Acne Scarring
Acne · Scar
Bottom Line
View on ClinicalTrials.gov: NCT00585286 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Overall Improvement of Acne Scarring — 2.26; 1.91 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 10,600 nm fractional carbon dioxide laser system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Improvement of Acne Scarring |
2.26; 1.91 | — |
| PRIMARY Average Improvement in Surface Texture |
1.94; 2.09 | — |
| PRIMARY Degree of Atrophy |
1.68; 1.65 | — |
| SECONDARY Pain Tolerance |
5.67 | — |
Summary
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).
Eligibility Criteria
Inclusion Criteria
- Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.)
- Are male or female.
- Are between 18 and 75 years of age.
- Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score > 4 according to the Acne Scar Severity Scale (0-9).
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements for a minimum of 8 months.
Exclusion Criteria
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have immunocompromised status (inability to resist infection, etc.)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Have taken Accutane within 12 months of enrollment
- Are allergic to lidocaine (skin numbing agent)
- Are allergic to Valtrex (an anti-viral medication)
Data sourced from ClinicalTrials.gov (NCT00585286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.