Acne VulgarisPhase 3NCT01584674
A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne
A Phase 3 study testing KLOX Biophotonic System in people with Acne Vulgaris, run by KLOX Technologies Inc. at 3 sites in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- KLOX Biophotonic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesGreece
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Physical or psychiatric condition the investigator deems would preclude participation in the study. (e.g. Polycystic Ovary disease)
- Unwillingness to refrain from excess sun exposure or tanning beds during the healing process -
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Attikon University General Hospital
Athens, 12462
Andreas Sygros Hospital
Athens, 16121
Papageorgiou Hospital
Thessaloniki, 56429
About this study
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
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
- Being tested
- KLOX Biophotonic System
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLOX Biophotonic SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: KLOX Biophotonic System |
| Control (untreated hemiface) | No intervention | No treatment will be administered on the control hemiface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale
Measured: 12 weeks
Secondary outcomes (6)
Reduction in inflammatory lesions
Measured: 6 and 12 weeks
Proportion of patients achieving a reduction of at least 1 grade in the Investigator's Global Assessment (IGA) scale
Measured: 6 and 12 weeks
Proportion of patients achieving a reduction to grade 1 or 0 in the Investigator's Global Assessment (IGA) scale
Measured: 6 and 12 weeks
Patient satisfaction questionnaire
Measured: 6 and 12 weeks
Pain assessment using a visual analogue scale
Measured: 12 weeks
Safety evaluations (treatment-emergent and treatment related adverse events)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLOX Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584674
- Sponsor's protocol ID
- CL-K1005-P001
- Status last verified
- May 2013
- First submitted
- 19 Apr 2012
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01584674
- Acronym / sponsor ID
- CL-K1005-P001
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- KLOX Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KLOX Biophotonic System | Experimental | Device: KLOX Biophotonic SystemKLOX 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 |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLOX Biophotonic SystemKLOX 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 |
Primary outcome
Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale
Time frame: 12 weeks
6 secondary outcomes
Reduction in inflammatory lesions
Time frame: 6 and 12 weeks
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
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
Patient satisfaction questionnaire
Time frame: 6 and 12 weeks
Pain assessment using a visual analogue scale
Time frame: 12 weeks
Safety evaluations (treatment-emergent and treatment related adverse events)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KLOX Biophotonic System in people with Acne Vulgaris, run by KLOX Technologies Inc. at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving a total reduction of at least 2 grades in the Investigator's Global Assessment (IGA) scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.