Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01584674
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
KLOX Technologies Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic System in patients with moderate to severe facial acne vulgaris using a split-face design (treated hemiface vs untreated hemiface).

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: KLOX Biophotonic System Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial Evaluating the Efficacy of the KLOX Biophotonic System (KLOX KLGA0105-01 and KLOX THERA LAMP) On Moderate to Severe Acne
Study Start Date : March 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: KLOX Biophotonic System
KLOX Biophotonic System (KLOX KLGA0105-01 photo-converter gel and KLOX THERA lamp) will be administered twice a week for 6 weeks followed by a 6-week follow up period
Device: KLOX Biophotonic System
KLOX Biophotonic System (KLOX KLGA0105-01 photo-converter gel and KLOX THERA lamp) will be administered twice a week for 6 weeks followed by a 6-week follow up period

No Intervention: Control (untreated hemiface)
No treatment will be administered on the control hemiface



Primary Outcome Measures :
  1. Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Reduction in inflammatory lesions [ Time Frame: 6 and 12 weeks ]
  2. Proportion of patients achieving a reduction of at least 1 grade in the Investigator's Global Assessment (IGA) scale [ Time Frame: 6 and 12 weeks ]
  3. Proportion of patients achieving a reduction to grade 1 or 0 in the Investigator's Global Assessment (IGA) scale [ Time Frame: 6 and 12 weeks ]
  4. Patient satisfaction questionnaire [ Time Frame: 6 and 12 weeks ]
  5. Pain assessment using a visual analogue scale [ Time Frame: 12 weeks ]
  6. Safety evaluations (treatment-emergent and treatment related adverse events) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female 16 - 30 years of age.
  2. Fitzpatrick skin type I through IV.
  3. Known medical history of active acne vulgaris for at least 6 months.
  4. Moderate-to-severe facial acne, as defined by:

    Moderate is defined as a patient with an IGA of 3 with 20 to 40 inflammatory lesions (papules and pustules) and no more than 1 nodule. Severe is defined as a patient with an IGA of 4 with a greater than 40 inflammatory lesions with the presence of no more than 2 nodules and/or inflammatory scaring type lesion. Also note that all patients should have a similar disease stage on both sides of their face.

  5. The patient must have a clinical examination prior to treatment.
  6. The patient must have signed the consent form.
  7. The patient must be willing to return for follow-up visits.
  8. Females of child bearing potential must have a negative pregnancy test result at baseline and both male and female patients must be willing to adhere to a birth control method.

Exclusion Criteria:

  1. Active skin infection on the face. Patient must not have active, localized or systemic infection.
  2. Facial aesthetic procedure, including laser therapy and injectables within the last 6 months.
  3. Enrollment in another acne study or other dermatological study using light therapy including tanning beds within 120 days of enrollment. Patients must not take part or intend to take part in another study liable to interfere with this study whatever the region of the body considered for 30 days prior to the study start and 30 days following completion of the study.
  4. History of head and/or neck irradiation.
  5. Use of a hormonal contraception is prohibited unless the birth control has been stable for the past 3 months. Note that patient that are presently taking or have taken in past 30 days Cyproterone Acetate + Ethinyl Estradiol (Diane-35) are not eligible for this study.
  6. Any facial dermatological conditions that could hinder or interfere with clinical assessments.
  7. Immunosuppression and/or cortisone therapy in the past 4 months.
  8. Bleeding diathesis.
  9. Medications or supplements affecting coagulation.
  10. Isotretinoin within the last 24 weeks.
  11. Pregnant, breast-feeding or pregnancy planned during the trial.
  12. History of facial nerve palsy or marked facial asymmetry.
  13. History of neuromuscular disorder.
  14. Prior facial surgery that alters subcutaneous tissues (e.g., rhytidectomy).
  15. Use of non-acne topical medication that could interfere with study treatment.
  16. Physical or psychiatric condition the investigator deems would preclude participation in the study. (e.g. Polycystic Ovary disease)
  17. Unwillingness to refrain from excess sun exposure or tanning beds during the healing process -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584674


Locations
Layout table for location information
Greece
Attikon University General Hospital
Athens, Greece, 12462
Andreas Sygros Hospital
Athens, Greece, 16121
Papageorgiou Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
KLOX Technologies Inc.

Layout table for additonal information
Responsible Party: KLOX Technologies Inc.
ClinicalTrials.gov Identifier: NCT01584674     History of Changes
Other Study ID Numbers: CL-K1005-P001
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases