Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment

• ClinicalTrials.gov Identifier: NCT01678482
• Recruitment Status: Completed
• First Posted: September 5, 2012
• Last Update Posted: September 5, 2012
• Sponsor: Home Skinovations Ltd.
• Information provided by (Responsible Party): Home Skinovations Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Monitor Acne Lessions Count Reduction as Result of Usinfg the Device	Device: light based device for treatment of acne	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: 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 Start Date: November 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm

Intervention/treatment

Experimental: lession count reduction post treatment; 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.

Device: light based device for treatment of acne

Outcome Measures

Primary Outcome Measures :

1. Acne lession count [ Time Frame: 3 months post treatment ]
   acne count post treatment compared to based line count

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Presence of mild to moderate acne.
2. Skin Type I to VI (Fitzpatrick).
3. Males or females who are 21-65 years old.
4. Willingness to follow the treatment schedule, post-treatment care and have photographs taken.

Exclusion Criteria:

1. Pacemaker or internal defibrillator.
2. Permanent implant in the treated area, such as metal plates and screws or silicon, unless deep enough in the bone.
3. Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat injections or other augmentation methods with bio-material during last 6 months.
4. Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
5. Current severe medical conditions, such as heart and lung disorders.
6. Pregnant or breastfeeding.
7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
8. History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores) in the treatment area, unless treated by following a preventive regime.
9. Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.
10. Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea.
11. History of skin disorders, keloids (excessive scarring), abnormal wound healing, as well as very dry and fragile skin.
12. History of bleeding disorders, or use of anticoagulants in the last 10 days.
13. Any facial surgery performed within 12 months prior to treatment.
14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
15. Received treatment with light, laser, radiofrequency (RF), or other devices in the treated area within 6 months.
16. Used isotretinoin (Accutane®) within 6 months prior to treatment.
17. Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) 1 week before and after each treatment session.
18. 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.
19. Subjects that have been on a steroid regimen within the past 3 months.

Contacts and Locations

Locations

Canada, Ontario

SpaMedica

Toronto, Ontario, Canada, M5R3N8

Sponsors and Collaborators

Home Skinovations Ltd.

More Information

• Responsible Party: Home Skinovations Ltd.
• ClinicalTrials.gov Identifier: NCT01678482
• Other Study ID Numbers: C1
• First Posted: September 5, 2012
• Last Update Posted: September 5, 2012
• Last Verified: August 2012

Keywords provided by Home Skinovations Ltd.:

Acne, LED, blue light

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases