Acne Scars - Mixed Atrophic and Hypertrophic
Conditions
Brief summary
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne scars.
Detailed description
This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks (± 2 weeks) following their final study treatment. 1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final treatment photographs from the baseline by at least two of the three blinded reviewers in 75% of the patients and an improvement of one point in the ASAS. 2. The Secondary Efficacy Endpoints as the: * Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatment as assessed by the investigator starting from the 2nd treatment onward, and * Subject satisfaction levels as assessed from the subject questionnaire completed at the final follow-up visit 12 weeks post final treatment. 3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array handpiece attachment as assessed by the frequency and severity of device related adverse events, 4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment for the improvement of skin quality as assessed by the investigator and/or blinded evaluators 12-weeks-post final study treatment.
Interventions
DEVICEother
no arm
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 65 years of age (inclusive). 3. Fitzpatrick Skin Type I - VI (Appendix 6). 4. Subject desires treatment for acne scars and wishes to undergo laser treatments for improvement. 5. Subject has bilateral moderate to severe signs of facial acne scarring. 6. Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece attachment treatments and able to adhere to the treatments, follow-up visit schedule, and post-treatment care instructions. 7. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period. 8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation (educational and/or marketing), publications, and any additional marketing purposes. 9. Agree to not undergo any other procedure(s) or treatment(s) for acne scars during the study and has no intention of having such procedures performed during the course of the study. 10. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study., \-
Exclusion criteria
1\. Participation in a clinical trial of another drug, or device administered to the treatment area, within 6 months prior to enrollment or during the study. 2\. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, facial fillers, i.e. (Bellafill) and those used for general aesthetic correction, facial peel, lightening creams, or facial surgery. 3\. Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity. 4\. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion). 5\. Pregnant and/or breastfeeding, or planning to become pregnant. 6. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication. 7\. Hypersensitivity to light exposure. 8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion. 9\. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising. 10\. Has a history of squamous cell carcinoma or melanoma in the treatment area. 11. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. 12\. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment. 13\. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma. 14\. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. 15\. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator. 16\. Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000 units per day) within 12 months of initial treatment or plans on using during the course of the study (note: skin must regain its normal degree of moisture prior to treatment, e.g. lack of noticeable skin flaking and peeling). 17\. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study. 19\. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment. 20\. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients. | 12 weeks post-final treatment | visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment with the 1064nm laser | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 43 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)
Time frame: 12 weeks post-final treatment
Population: Number of patients who completed at least 1 treatment and the 12 week follow up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients. | 31 Participants |