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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control (untreated hemiface) | No Intervention | No treatment will be administered on the control hemiface |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attikon University General Hospital | Athens | 12462 | Greece | |||
| Andreas Sygros Hospital |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| 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 |
| Safety evaluations (treatment-emergent and treatment related adverse events) | 12 weeks |
| Athens |
| 16121 |
| Greece |
| Papageorgiou Hospital | Thessaloniki | 56429 | Greece |