Evaluation of the Safety and Efficacy of an Acne Treatment Device

NCT06420804 | Completed FDA Device

• 1 other identifier: DCS-46-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Acne

Keywords

Acne, Acne self care, Adult facial acne

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Safety Assessment

  12 weeks

Other Outcomes (1)

• Tolerability Assessment

  12 weeks

Study Arms (1)

Single-site monadic study

EXPERIMENTAL

Single-site monadic study to evaluate the effect of a device on acne treatment.

Device: ZIIP Acne Treatment Device

Interventions

ZIIP Acne Treatment Device DEVICE

Evaluation of the Safety and Efficacy of a ZIIP Acne Treatment Device

Also known as: Historical Control

Single-site monadic study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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. .
• 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."

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ZIIP Beauty: lead
• Dermatology Consulting Services, PLLC: collaborator

Study Sites (1)

ZIIP Beauty

Pleasant Hill, California, 94523, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Historically Controlled Study

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques

Study Officials

• Zoe D Draelos, MD

  Lead Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-site monadic study to evaluate the effect of a device on acne treatment.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: October 15, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 3, 2021
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)