Completed

Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for the Treatment of Mild to Moderate Inflammatory Acne.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

light based device for treatment of acne

Device
Who is being recruted

Sebaceous Gland Diseases+2

+ Skin Diseases

+ Skin and Connective Tissue Diseases

From 21 to 65 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2011
See protocol details

Summary

Principal SponsorHome Skinovations Ltd.
Last updated: September 5, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

The subjects will be recruited if they are eligible to participate in the study according with the device labeling presented at the doctor's office by printed ads. Subjects will be given information about the Clear device according to its labeling. After reading the information and labeling, it will be the subjects' decision if they understand the device label information and if they want to participate in the study. The investigator will review the inclusion / exclusion criteria with the subjects to ensure eligibility.

NCT01678482
Principal SponsorHome Skinovations Ltd.
Last updated: September 5, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Sebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsAcne Vulgaris

Criteria

4 inclusion criteria required to participate
Males or females who are 21-65 years old
Presence of mild to moderate acne
Skin Type I to VI (Fitzpatrick)
Willingness to follow the treatment schedule, post-treatment care and have photographs taken
19 exclusion criteria prevent from participating
Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea
Any facial surgery performed within 12 months prior to treatment
Current or history of skin cancer, or any other type of cancer, or pre-malignant moles
Current severe medical conditions, such as heart and lung disorders
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A total of 50 subjects were included. The majority are female (62 %) At baseline the average number of lesions was 20.5±7.1, ranging from 6 to 36 lesions. All subjects demonstrated a reduction in lesion count. The average improvement after one month was 56.7%±8.9%, and remained similar also after 3 months 57.7%±9.4%. The percent of responders (with at least 40% of reduction) was 94% after 1 month and 96% after 3 months The Percent of responders is similar for males & females and similar for cheeks & front.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

SpaMedica

Toronto, CanadaOpen SpaMedica in Google Maps
CompletedOne Study Center