Back to resultsClinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
Primary Purpose
Monitor Acne Lessions Count Reduction as Result of Usinfg the Device
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
light based device for treatment of acne
Sponsored by
About this trial
This is an interventional treatment trial for Monitor Acne Lessions Count Reduction as Result of Usinfg the Device focused on measuring Acne, LED, blue light
Eligibility Criteria
Inclusion Criteria:
- Presence of mild to moderate acne.
- Skin Type I to VI (Fitzpatrick).
- Males or females who are 21-65 years old.
- Willingness to follow the treatment schedule, post-treatment care and have photographs taken.
Exclusion Criteria:
- Pacemaker or internal defibrillator.
- Permanent implant in the treated area, such as metal plates and screws or silicon, unless deep enough in the bone.
- Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- 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.
- Pregnant or breastfeeding.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores) in the treatment area, unless treated by following a preventive regime.
- Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.
- Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea.
- History of skin disorders, keloids (excessive scarring), abnormal wound healing, as well as very dry and fragile skin.
- History of bleeding disorders, or use of anticoagulants in the last 10 days.
- Any facial surgery performed within 12 months prior to treatment.
- Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
- Received treatment with light, laser, radiofrequency (RF), or other devices in the treated area within 6 months.
- Used isotretinoin (Accutane®) within 6 months prior to treatment.
- Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) 1 week before and after each treatment session.
- Subjects that are currently or have recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
- Subjects that have been on a steroid regimen within the past 3 months.
Sites / Locations
- SpaMedica
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lession count reduction post treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Acne lession count
acne count post treatment compared to based line count
Secondary Outcome Measures
Full Information
NCT ID
NCT01678482
First Posted
August 31, 2012
Last Updated
August 31, 2012
Sponsor
Home Skinovations Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01678482
Brief Title
Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
Official Title
Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for the Treatment of Mild to Moderate Inflammatory Acne.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Home Skinovations Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a clinical research study to determine the ability of the Clear device to treat mild to moderate inflammatory acne, and to determine if the average person is able to use the device properly according to the labeling as describe in the operator manual.
The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in which the subjects will be treating themselves with the Clear device, and 2 follow-up visits to evaluate the results. The clinical result will be assessed by the investigator for improvement in the acne condition. Treatment will be performed on the face of subjects enrolled and who meet the inclusion criteria.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monitor Acne Lessions Count Reduction as Result of Usinfg the Device
Keywords
Acne, LED, blue light
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lession count reduction post treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
light based device for treatment of acne
Primary Outcome Measure Information:
Title
Acne lession count
Description
acne count post treatment compared to based line count
Time Frame
3 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of mild to moderate acne.
Skin Type I to VI (Fitzpatrick).
Males or females who are 21-65 years old.
Willingness to follow the treatment schedule, post-treatment care and have photographs taken.
Exclusion Criteria:
Pacemaker or internal defibrillator.
Permanent implant in the treated area, such as metal plates and screws or silicon, unless deep enough in the bone.
Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat injections or other augmentation methods with bio-material during last 6 months.
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.
Pregnant or breastfeeding.
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores) in the treatment area, unless treated by following a preventive regime.
Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.
Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea.
History of skin disorders, keloids (excessive scarring), abnormal wound healing, as well as very dry and fragile skin.
History of bleeding disorders, or use of anticoagulants in the last 10 days.
Any facial surgery performed within 12 months prior to treatment.
Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
Received treatment with light, laser, radiofrequency (RF), or other devices in the treated area within 6 months.
Used isotretinoin (Accutane®) within 6 months prior to treatment.
Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) 1 week before and after each treatment session.
Subjects that are currently or have recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
Subjects that have been on a steroid regimen within the past 3 months.
Facility Information:
Facility Name
SpaMedica
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5R3N8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
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