Acne VulgarisNCT01052246
Pulsed Dye Laser Treatment of Acne Vulgaris
A study testing Fixed combination of clindamycin 1% + benzoyl peroxide 5% and Pulsed dye laser in people with Acne Vulgaris, run by Laserklinik Karlsruhe at 1 site in Germany.
Trial summary
The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Fixed combination of clindamycin 1% + benzoyl peroxide 5% and Pulsed dye laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Sep 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescents and adults with moderate inflammatory acne vulgaris (ISGA degrees 2-4)
- Fitzpatrick skin type I-III
Who cannot join
- Atopic dermatitis
- Oral antibiotics during the last 4 weeks prior to enrolment
- Oral isotretinoin during the last 52 weeks prior to enrolment
- Oral contraceptives during the last 26 weeks prior to enrolment
- Topical acne therapeutics during the last 4 weeks prior to enrolment
- Diagnosis or anamnestic indication of a regional enteritis, Morbus Crohn or antibiotics-associated colitis
Show all 10Show fewer
- Laser surgery interventions within the treatment region during the last 12 weeks prior to enrolment
- Coagulation anomalies or anticoagulant treatment
- Photo-sensitizing medication (e. g., tetracycline, gold)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial
The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said results in a similar, albeit not identical, study design. More recently published studies failed to resolve the controversy, varying in terms of treatment procedure(s) as well as results.
While published results are certainly promising enough to be followed up by independent research, they are insufficient to justify the abdication of methods with proven efficacy. Considering patient treatment ethics and the short 'window of opportunity' for scar prevention when active inflammatory lesions are present, the investigators planned the adjuvant application of the PDL in the present study, providing all patients with the well established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial inflammatory acne.
- Conditions
- Acne Vulgaris
- Being tested
- Fixed combination of clindamycin 1% + benzoyl peroxide 5%, Pulsed dye laser
- Keywords
- acne vulgaris, laser surgery, pulsed dye lasers, benzoyl peroxidase, clindamycin, randomized controlled trial
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed combination of clindamycin 1% + benzoyl peroxide 5%Drug
Topical monotherapy with a fixed combination of 1% clindamycin and 5% benzoyl peroxide hydrating gel (Duac® Akne Gel, Stiefel Laboratorium GmbH, Offenbach, Germany). In order to provide standardized condition within the sample, the gel was applied on the whole face regardless of the lesion location. The gel was applied once per day in the evening throughout the observation period and left in place overnight.
Pulsed dye laserDevice
Patients randomized in the experimental group received two additional treatments with a pulsed dye laser using the following parameters:
- Wavelength 585 nm
- Energy fluence 3 J/cm2
- Pulse duration 0.35 msec
- Spot size 7 mm
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser | Experimental | Not described Receives: Device: Pulsed dye laser |
| Clindamycin 1% + benzoyl peroxide 5% | Active comparator | Not described Receives: Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Static Global Assessment
Measured: day 0, day 14, day 28
Lesions count
Measured: day 0, day 28
Secondary outcomes (2)
Dermatology Life Quality Index
Measured: day 0, day 28
Documentation of side effects
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionSep 2009
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laserklinik Karlsruhe
- Sponsor type
- University, hospital or other
- Investigators
- Syrus Karsai, MD, Principal investigator, Laserklinik Karlsruhe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052246
- Sponsor's protocol ID
- LK_08_2009
- Status last verified
- Jan 2010
- First submitted
- 19 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial
- ClinicalTrials.gov ID
- NCT01052246
- Acronym / sponsor ID
- LK_08_2009
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, laser surgery, pulsed dye lasers, benzoyl peroxidase, clindamycin, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laserklinik KarlsruheUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Jan 2010 (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 results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said results in a similar, albeit not identical, study design. More recently published studies failed to resolve the controversy, varying in terms of treatment procedure(s) as well as results.
While published results are certainly promising enough to be followed up by independent research, they are insufficient to justify the abdication of methods with proven efficacy. Considering patient treatment ethics and the short 'window of opportunity' for scar prevention when active inflammatory lesions are present, the investigators planned the adjuvant application of the PDL in the present study, providing all patients with the well established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial inflammatory acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser | Experimental | Device: Pulsed dye laser |
| Clindamycin 1% + benzoyl peroxide 5% | Active comparator | Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adolescents and adults with moderate inflammatory acne vulgaris (ISGA degrees 2-4)
- Fitzpatrick skin type I-III
Key exclusion criteria (10 listed)
- Atopic dermatitis
- Oral antibiotics during the last 4 weeks prior to enrolment
- Oral isotretinoin during the last 52 weeks prior to enrolment
- Oral contraceptives during the last 26 weeks prior to enrolment
- Topical acne therapeutics during the last 4 weeks prior to enrolment
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 |
|---|---|---|
| Fixed combination of clindamycin 1% + benzoyl peroxide 5%Topical monotherapy with a fixed combination of 1% clindamycin and 5% benzoyl peroxide hydrating gel (Duac® Akne Gel, Stiefel Laboratorium GmbH, Offenbach, Germany). In order to provide standardized condition within the sample, the gel was applied on the whole face regardless of the lesion location. The gel was applied once per day in the evening throughout the observation period and left in place overnight. | Drug | Clindamycin 1% + benzoyl peroxide 5% |
| Pulsed dye laserPatients randomized in the experimental group received two additional treatments with a pulsed dye laser using the following parameters: * Wavelength 585 nm * Energy fluence 3 J/cm2 * Pulse duration 0.35 msec * Spot size 7 mm | Device | Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser |
Primary outcome
Investigator's Static Global Assessment
Time frame: day 0, day 14, day 28
Lesions count
Time frame: day 0, day 28
2 secondary outcomes
Dermatology Life Quality Index
Time frame: day 0, day 28
Documentation of side effects
Time frame: day 28
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 20 Jan 2010.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Syrus Karsai, MD principal investigator
Laserklinik Karlsruhe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed combination of clindamycin 1% + benzoyl peroxide 5% and Pulsed dye laser in people with Acne Vulgaris, run by Laserklinik Karlsruhe at 1 site in Germany.
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 2 inclusion and 10 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 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Investigator's Static Global Assessment (time frame: day 0, day 14, day 28). The study lists 2 primary outcomes in all. 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 20 Jan 2010.