Acne Scars, Pigmentation, Wrinkles
Conditions
Keywords
wrinkles, acne scars, pigmentation
Brief summary
To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and pigmented skin.
Detailed description
This is a randomized, split face & dorsal hand side by side study. The purpose of the side by side study is to determine whether the use of the Impact with the ablative fractional 2940nm laser and cosmetics improves the cosmetic outcomes when compared to using just the ablative fractional 2940nm laser with the cosmetics. This is a non-significant risk aesthetic clinical study. Only cosmetic formulations will be used during the study, These cosmetic formulations do not contain any ingredient categorized as a drug by the FDA.
Interventions
DEVICEErbium 2940 plus cosmetics plus Impact
Laser used in all arms
DEVICEErbium 2940 plus cosmetics
laser
Sponsors
Alma Lasers Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female in good general health between 35 to 65 years of age. * Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit. * A potential subject must exhibit: Facial wrinkling, acne scars or pigmentation. * For FEMALE PATIENTS OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study \[i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active\]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation. * Must be willing to comply with study visits and complete the entire course of the study.
Exclusion criteria
Subjects meeting any of the following criteria will be excluded from participation: The following are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Photographs to determine improvement of appearance | 4 months | An independent panel of qualified blinded physicians (masked) with respect to subject-identity, photo chronology, treatment methodology (with/without Impact module), study time point, and treatment assignment will grade the photographs as determined by: 1. Clinical Photographs Alexiades-Armenakas Grading Scale Assessment 2. Clinical Photographs Acne Scar Grading Scale (see section 7.1) 3. Clinical Photographs Hand Pigmentation Grading Scale (see section 7.1) 4. Spectrophotometric (Reflectance Spectroscopy) Analysis of La\*b\* values |
Countries
United States
Outcome results
None listed