Mild to Moderate AcneNCT06420804
Evaluation of the Safety and Efficacy of an Acne Treatment Device
A study testing ZIIP Acne Treatment Device in people with Mild to Moderate Acne, run by ZIIP Beauty at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mild to Moderate Acne
- What is being tested?
- ZIIP Acne Treatment Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 3 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The following represented the inclusion criteria:
- Subjects with mild to moderate acne (5-30 inflammatory lesions and no nodules/cysts).
- Male and female subjects age 18-50 years.
- Subjects with all Fitzpatrick skin types.
- Subjects of all complexion types (normal, oily, dry, combination).
- Subjects must have an acne lesion in all 4 zones. .
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- Subjects who have used the same moisturizer without difficulty for 30 days and will continue using same moisturizer during the 12-week study.
- Subjects agree not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, or powder).
- Subjects who are using no other acne products for the duration of the study.
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- 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.
- Subjects have signed an Informed Consent Form in compliance with 21CFR, Part 50: "Protection of Human Subjects."
Who cannot join
- The following represented the exclusion criteria:
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
- Subjects who are not willing to use the assigned study device to their face as instructed.
- Subjects who have used any topical prescription or OTC acne products for 2 weeks prior to study entry.
- Subjects who have taken any oral prescription or OTC acne products for 4 weeks prior to study entry.
- Subjects who have used a non-OTC cleanser without benzoyl peroxide, sulfur or salicylic acid for at least 2 weeks prior to study entry.
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- Subject who have not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, and/or facial plastic surgery.
- Subjects who are pregnant, breast feeding or planning a pregnancy.
- Subjects with clinically significant and/or unstable medical disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects who have a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Subjects who have undergone recent facial surgery.
- Subjects currently participating in any other clinical trial.
- Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to the study entry; or who plan on starting, stopping or changing doses of HRT or hormones for birth control during the study.
- Subjects who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.
- Subjects who are wearing EKG monitoring equipment.
- Subjects with phlebitis, thrombophlebitis, broken capillaries, or varicose veins.
- Subjects who have seizures, epilepsy, or cancer/tumors.
- Subjects who have a history of hypertrophic scarring or keloid formation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mild to Moderate Acne
- Being tested
- ZIIP Acne Treatment Device
- Keywords
- Acne, Acne self care, Adult facial acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIIP Acne Treatment DeviceDevice
Also called Historical Control
Evaluation of the Safety and Efficacy of a ZIIP Acne Treatment Device
| Study group | Role | What they receive |
|---|---|---|
| Single-site monadic study | Experimental | Single-site monadic study to evaluate the effect of a device on acne treatment. Receives: Device: ZIIP Acne Treatment Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Safety Assessment
The safety endpoint was the absence of significant adverse reactions. No adverse reactions occurred.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start15 Oct 2020
- Primary completion1 Sep 2021
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-site monadic study to evaluate the effect of a device on acne treatment.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZIIP Beauty
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, PLLC
- Responsible party
- Sponsor
- Investigators
- Zoe D Draelos, MD, Principal investigator, Lead Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420804
- Sponsor's protocol ID
- DCS-46-20
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this time there is no plan to share IPD data
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of an Acne Treatment Device
- ClinicalTrials.gov ID
- NCT06420804
- Acronym / sponsor ID
- DCS-46-20
- Conditions
- Mild to Moderate Acne
- Keywords
- Acne, Acne self care, Adult facial acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ZIIP BeautyIndustry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, PLLC
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-site monadic study to evaluate the effect of a device on acne treatment.
| Arm | Type | Receives |
|---|---|---|
| Single-site monadic study | Experimental | Device: ZIIP Acne Treatment DeviceSingle-site monadic study to evaluate the effect of a device on acne treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The following represented the inclusion criteria:
Key exclusion criteria (19 listed)
- The following represented the exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZIIP Acne Treatment DeviceAlso: Historical ControlEvaluation of the Safety and Efficacy of a ZIIP Acne Treatment Device | Device | Single-site monadic study |
Primary outcome
Efficacy Assessment
Time frame: 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.
1 secondary outcome
Safety Assessment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No. At this time there is no plan to share IPD data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoe D Draelos, MD principal investigator
Lead Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZIIP Acne Treatment Device in people with Mild to Moderate Acne, run by ZIIP Beauty at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.