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

NCT01584674 | Completed Phase 3

• 1 other identifier: CL-K1005-P001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

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).

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale

  12 weeks

Secondary Outcomes (6)

• Reduction in inflammatory lesions

  6 and 12 weeks

• Proportion of patients achieving a reduction of at least 1 grade in the Investigator's Global Assessment (IGA) scale

  6 and 12 weeks

• Proportion of patients achieving a reduction to grade 1 or 0 in the Investigator's Global Assessment (IGA) scale

  6 and 12 weeks

• Patient satisfaction questionnaire

  6 and 12 weeks

• Pain assessment using a visual analogue scale

  12 weeks

Study Arms (2)

KLOX Biophotonic System

EXPERIMENTAL

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

Control (untreated hemiface)

NO INTERVENTION

No treatment will be administered on the control hemiface

Interventions

KLOX Biophotonic System DEVICE

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

KLOX Biophotonic System

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or Female 16 - 30 years of age.
• Fitzpatrick skin type I through IV.
• Known medical history of active acne vulgaris for at least 6 months.
• 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.
• The patient must have a clinical examination prior to treatment.
• The patient must have signed the consent form.
• The patient must be willing to return for follow-up visits.
• 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.

You may not qualify if:

• Active skin infection on the face. Patient must not have active, localized or systemic infection.
• Facial aesthetic procedure, including laser therapy and injectables within the last 6 months.
• 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.
• History of head and/or neck irradiation.
• 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.
• Any facial dermatological conditions that could hinder or interfere with clinical assessments.
• Immunosuppression and/or cortisone therapy in the past 4 months.
• Bleeding diathesis.
• Medications or supplements affecting coagulation.
• Isotretinoin within the last 24 weeks.
• Pregnant, breast-feeding or pregnancy planned during the trial.
• History of facial nerve palsy or marked facial asymmetry.
• History of neuromuscular disorder.
• Prior facial surgery that alters subcutaneous tissues (e.g., rhytidectomy).
• Use of non-acne topical medication that could interfere with study treatment.

Sponsors & Collaborators

• KLOX Technologies Inc.: lead

Study Sites (3)

Attikon University General Hospital

Athens, 12462, Greece

Location

Andreas Sygros Hospital

Athens, 16121, Greece

Location

Papageorgiou Hospital

Thessaloniki, 56429, Greece

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 25, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

GR (3)