CompletedNot Applicable

Evaluation of the Safety and Efficacy of an Acne Treatment Device

United States50 participantsStarted 2020-10-15

Plain-language 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.

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Efficacy Assessment

Timeframe: 12 weeks

NCT IDNCT06420804

SponsorZIIP Beauty

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-01

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.