NCT01613924

Brief Summary

The aim of our study is to determine the time to resolution of individual acne lesions using a popular handheld heat based device in comparison to no treatment and to standard topical therapy with benzoyl peroxide in order to determine its effectiveness in the spot treatment of acne vulgaris. Patient satisfaction and potential side effects will be examined as well.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

May 30, 2012

Last Update Submit

December 2, 2015

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Time to resolution of individual acne lesions

    Subjects will be photographed daily and the progression of individual acne lesions will be followed. Time to resolution of each lesion will be determined for the various treatment groups.

    5 days

Secondary Outcomes (3)

  • Device tolerability

    5 days

  • Split-face investigator's static global assessment

    5 days

  • Acne lesion counts

    5 days

Study Arms (2)

Heat based treatment/no treatment

PLACEBO COMPARATOR

Split face treatment with handheld acne heat based device and no treatment

Device: Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment

Heat based treatment/benzoyl peroxide

ACTIVE COMPARATOR

Split face treatment with handheld acne heat based device and benzoyl peroxide 4%

Device: Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%

Interventions

Split face: handheld acne heat based device (Zeno Hot Spot) and no treatmentDEVICE

Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face at 6 hour intervals for a total of 3 treatments. Follow up will occur daily over a 5 day period.

Heat based treatment/no treatment
Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%DEVICE

Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face at 6 hour intervals for a total of 3 treatments. Subjects will apply benzoyl peroxide to the other half of the face daily for 5 days.

Heat based treatment/benzoyl peroxide

Eligibility Criteria

Age12 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Are 12- 64 years old
  • Have an Investigator's Global Assessment of greater than or equal to 2
  • Have 8-16 inflammatory acne facial lesions (papules and pustules)

You may not qualify if:

  • Have any severe facial acne at baseline, including large acne lesions and cysts (nodulocystic acne)
  • Have used any topical anti-acne medications, systemic antibiotics, and/or systemic corticosteroids 4 weeks before the study start
  • Have used oral acne medications, such as Accutane (systemic retinoid), 6 months before the study start
  • Have had a facial procedure 2 weeks before the study start
  • Are nursing or pregnant
  • Are using any oral contraceptives that have a specific anti-androgenic action or if you have started using a new oral contraceptive 12 weeks before the study start
  • Are using any medications known to exacerbate acne
  • Have a known hypersensitivity or allergy to benzoyl peroxide or any of the vehicle constituents
  • Have a beard or facial hair that could interfere with study evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Care Centre

Vancouver, British Columbia, V5Z4E8, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Shannon Humphrey, MD, FRCPC

    UBC Department of Dermatology and Skin Science

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 7, 2012

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

CA(1)