Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment
NCT ID: NCT01678482
Last Updated: 2012-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-11-30
2012-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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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.
light based device for treatment of acne
Interventions
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light based device for treatment of acne
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
65 Years
ALL
Yes
Sponsors
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Home Skinovations Ltd.
INDUSTRY
Responsible Party
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Locations
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SpaMedica
Toronto, Ontario, Canada
Countries
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Other Identifiers
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C1
Identifier Type: -
Identifier Source: org_study_id