Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris

NCT02924428 | Terminated Results

• 1 other identifier: CS2715
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual applicator using two intense pulsed light wavelength bands.

Conditions

Acne Vulgaris

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• Improvement in Acne Vulgaris Appearance

  Treatment will be considered successful if the appearance improves by at least 2 points on the 5-point Global Acne Assessment Score (GAAS) at 6 weeks post treatment as compared to baseline where 0 = No evidence of facial acne vulgaris, 1 (minimal) = Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) may be present, 2 (mild) = Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present, 3 (Moderate) = Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed, 4 (Severe) = Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present. Lower number represents an improvement in acne vulgaris.

  Week 10 (6 weeks after last treatment)

Secondary Outcomes (7)

• Reduction of Inflammatory Lesions and Non-inflammatory Lesions

  Week 10 (6 weeks after last treatment)

• Subject Improvement Assessment in Treatment Area Appearance

  Week 10 (6 weeks after last treatment)

• Subject Assessment of Pain and Discomfort Associated With Treatments

  Immediately after each applicator treatment at Week 1

• Subject Satisfaction With Treatment Outcome

  Week 10 (6 weeks after last treatment)

• Subject Assessment of Improvement in Acne Related 'Quality of Life'

  Baseline

Study Arms (2)

Diamondpolar applicator, AC Dual applicator

EXPERIMENTAL

Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.

Device: Venus Versa

AC Dual applicator treatment

ACTIVE COMPARATOR

Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system. The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.

Device: Venus Versa

Interventions

Venus Versa DEVICE

AC Dual applicator treatment; Diamondpolar applicator, AC Dual applicator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fitzpatrick skin phototype I - VI
• Having mild to moderate acne vulgaris (as defined by the Acne Global Severity Scale) and have at least 10 inflammatory and 15 non-inflammatory lesions, but no nodulo-cystic lesions.
• Subject who can commit to all treatments and follow up.

You may not qualify if:

• Superficial metal or other implants in the treatment area.
• Current or history of cancer, or current condition of any type of cancer, or pre-malignant moles.
• Pregnancy and nursing.
• Patients with cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc)
• Diseases which may be stimulated by light at the wavelengths used, such as history of Systemic Lupus Erythematosus, Porphyria, and Epilepsy.
• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• Poorly controlled endocrine disorders, such as Diabetes or Polycystic Ovary Syndrome.
• Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash.
• Tattoos, scars or piercings in the treated area.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last six months, tetracyclines, or St. John's Wort within the last two weeks.
• Any surgical procedure in the treatment area within the last three months or before complete healing.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: Venus Concept Ltd.

mgronski@venusconcept.com

416-222-6144

Study Officials

• Joseph L Reiz

  Venus Concept Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: June 5, 2018
• Study Completion: October 1, 2018
• Last Updated: November 9, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)