Mild to Moderate Acne
Conditions
Keywords
Acne, Acne self care, Adult facial acne
Brief summary
A 50-patient study in which 400 microamps of direct current was applied 3 days per week. All tolerability, safety and efficacy endpoints were met.
Detailed description
A 50-patient study in which 400 microamps of direct current, applied 3 days per week on non-consecutive days, on all areas afflicted by acne. The results were as follow: TOLERABILITY ASSESSMENT The tolerability endpoint was the investigator-assessed absence of skin irritation from the facial study device at any time during the 12-week study. The tolerability endpoint was met. No statistically significant skin irritation was observed by the dermatologist investigator at any time during the study. SAFETY ASSESSMENT The safety endpoint was the absence of significant adverse reactions. No adverse reactions occurred. The safety endpoint was met. EFFICACY ASSESSMENT The efficacy endpoint was the investigator assessed improvement in investigator global assessment (IGA) after 12 weeks of every other day device use as compared to baseline. The efficacy endpoint was met. There was a 62% reduction in inflammatory lesions and a 49% reduction in noninflammatory lesions at week 12. The IGA was reduced by 44% after 12 weeks of device use from a baseline average of 2.56 to a week 12 average of 1.42. The ZIIP Acne Treatment Study was conducted in compliance with 21 CFR Parts 50, 56 and 812. No protocol deviations were reported during the ZIIP Acne Treatment Study.
Interventions
DEVICEZIIP Acne Treatment Device
Evaluation of the Safety and Efficacy of a ZIIP Acne Treatment Device
Sponsors
Dermatology Consulting Services, PLLC
ZIIP Beauty
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-site monadic study to evaluate the effect of a device on acne treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* The following represented the inclusion criteria: 1. Subjects with mild to moderate acne (5-30 inflammatory lesions and no nodules/cysts). 2. Male and female subjects age 18-50 years. 3. Subjects with all Fitzpatrick skin types. 4. Subjects of all complexion types (normal, oily, dry, combination). 5. Subjects must have an acne lesion in all 4 zones. . 6. Subjects who have used the same moisturizer without difficulty for 30 days and will continue using same moisturizer during the 12-week study. 7. Subjects agree not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, or powder). 8. Subjects who are using no other acne products for the duration of the study. 9. No known medical conditions that, in the investigator's opinion, may interfere with study participation. 10. Women of childbearing potential were willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant®, Depo-Provera®, double barrier methods (e.g., condom and spermicide) and abstinence. 11. Subjects have signed an Informed Consent Form in compliance with 21CFR, Part 50: Protection of Human Subjects.
Exclusion criteria
* The following represented the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Assessment | 12 weeks | The efficacy endpoint was the investigator assessed improvement in investigator global assessment (IGA) after 12 weeks of every other day device use as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 12 weeks | The safety endpoint was the absence of significant adverse reactions. No adverse reactions occurred. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Assessment | 12 weeks | The tolerability endpoint was the investigator-assessed absence of skin irritation from the facial study device at any time during the 12-week study. |
Countries
United States
Outcome results
None listed