Acne Vulgaris
Conditions
Brief summary
To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.
Interventions
DEVICECutera Laser System
Subjects will receive laser treatments
Sponsors
Cutera Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcome Assessor is blinded to study design and time point being assessed.
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Female or Male, 16 to 60 years of age (inclusive) 2. Fitzpatrick Skin Type I-VI 3. Has clinically diagnosed acne vulgaris of severity grade 2 - 4 on the face using the Investigator's Global Assessment Scale. 4. Has inflammatory acne lesions on the face as determined by the Investigator (or qualified designee). 5. Subject (and parent or legal guardian if subject is a minor under age 18) must be able to read, speak, and understand English and sign the Informed Consent Form. 6. Willing to stop using topical retinoids and other acne medications for 1 month (30 days) prior to baseline and for the duration of the study. If the acne medication is topical, the washout applies to use on the face only. 7. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions. 8. Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an approved sunscreen of SPF 30 or higher on the face every day for the duration of the study, including the follow-up period. 9. Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes. 10. Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study.
Exclusion criteria
1. Has clinically diagnosed acne vulgaris of severity grade 0 or 1 on the face using the Investigator's Global Assessment Scale. 2. Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation. 3. Prior treatment to the target area within 3 months of study participation including chemical peel, dermabrasion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery. 4. Prior injection of botulinum toxin in the target area within 3 months of study participation and for the duration of the study. 5. Prior injection of collagen, hyaluronic acid filler or other dermal filler in the target area within 6 weeks of study participation. 6. Systemic use of retinoid, such as isotretinoin, within 6 months of study participation. 7. History of malignant tumors in the target area. 8. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris in the target area (okay if shaved). 9. Pregnant and/or breastfeeding or planning to become pregnant during the study. 10. Presence of any skin condition in the target area (e.g. eczema, psoriasis, dermatitis, rash, papulo-pustular rosacea, infection) that would interfere with the diagnosis or assessment of acne vulgaris. 11. Any medical condition that, in the opinion of the Investigator, would interfere with patient's participation in the full study protocol (e.g. severe Diabetes Mellitus or Cardiovascular Disease). 12. Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications. 13. History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. 14. History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma. 15. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion. 16. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen. 17. History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer. 18. History of diagnosed pigmentary disorders (including vitiligo) in the target area. 19. Excessively tanned on the face or unable/unlikely to refrain from tanning on the face during the study. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Treatment Success | 12 weeks post final treatment, up to 24 weeks | Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment Cutera Laser System: Subjects will receive laser treatments | 104 |
| Total | 104 |
Baseline characteristics
| Characteristic | Laser Treatment |
|---|---|
| Age, Continuous | 22.2 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 104 |
| other Total, other adverse events | 104 / 104 |
| serious Total, serious adverse events | 0 / 104 |
Outcome results
Primary
Percentage of Participants Achieving Treatment Success
Primary effectiveness objective was to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline
Time frame: 12 weeks post final treatment, up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laser Treatment | Percentage of Participants Achieving Treatment Success | 81 Participants |