Acne VulgarisPhase 2NCT00113425
Non-cutting Laser Therapy in the Treatment of Acne
A Phase 2 study testing V-Beam laser, Candela Corp., 595 nm wavelength in people with Acne Vulgaris, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- V-Beam laser, Candela Corp., 595 nm wavelength
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15 years or older of either gender and of any racial/ethnic group.
- Presence of clinically-evident facial acne.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Who cannot join
- Oral retinoid (Accutane) use within 6 months of entry into the study.
- Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
- Microdermabrasion or superficial chemical peels at the sites to be treated within 2 months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
- Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
Show all 14Show fewer
- Non-compliant subjects.
- Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
- Subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study.
- Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
- History of keloid (excessive scar) formation for subjects undergoing biopsies.
- Pregnant or nursing females.
- Subjects with known allergy or hypersensitivity to topical photosensitizing agents.
- Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
Official title: Photodynamic Therapy in the Treatment of Acne Vulgaris
The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.
Read the detailed description
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available.
We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production.
- Conditions
- Acne Vulgaris
- Being tested
- V-Beam laser, Candela Corp., 595 nm wavelength
- Keywords
- non-ablative laser, acne, photosensitizer, photodynamic therapy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-Beam laser, Candela Corp., 595 nm wavelengthDevice
Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Laser Therapy | Experimental | V-Beam laser, Candela Corp., 595 nm wavelength Receives: Device: V-Beam laser, Candela Corp., 595 nm wavelength |
| Control | No intervention | Untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Papule Acne Lesions at Week 10
Measured: Baseline and Week 10
Change From Baseline in Pustule Acne Lesions at Week 10
Measured: Baseline and Week 10
Change From Baseline in Cysts at Week 10
Measured: Baseline and Week 10
Change From Baseline in Closed Comedones at Week 10
Measured: Baseline and Week 10
Change From Baseline in Open Comedones at Week 10
Measured: Baseline and Week 10
Change From Baseline in Erythematous Macules at Week 10
Measured: Baseline and Week 10
Change From Baseline in Acne Severity at Week 10
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Measured: Baseline and Week 10
Secondary outcomes (7)
Change From Baseline in Papule Acne Lesions at Week 16
Measured: Baseline and Week 16
Change From Baseline in Pustule Acne Lesions at Week 16
Measured: Baseline and Week 16
Change From Baseline in Cysts at Week 16
Measured: Baseline and Week 16
Change From Baseline in Closed Comedones at Week 16
Measured: Baseline and Week 16
Change From Baseline in Open Comedones at Week 16
Measured: Baseline and Week 16
Change From Baseline in Erythematous Macules at Week 16
Measured: Baseline and Week 16
Change From Baseline in Acne Severity at Week 16
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey S. Orringer, University of Michigan
- Investigators
- John J Voorhees, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113425
- Sponsor's protocol ID
- Derm 548
- Status last verified
- Aug 2016
- First submitted
- 7 Jun 2005
- Last updated
- 18 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00113425
- Acronym / sponsor ID
- Derm 548
- Conditions
- Acne Vulgaris
- Keywords
- non-ablative laser, acne, photosensitizer, photodynamic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 8 Jun 2005 (estimated)
- Results
- Posted 18 Oct 2016
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 research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.
Detailed description
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available.
We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Therapy | Experimental | Device: V-Beam laser, Candela Corp., 595 nm wavelengthV-Beam laser, Candela Corp., 595 nm wavelength |
| Control | No intervention | –Untreated |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 15 years or older of either gender and of any racial/ethnic group.
- Presence of clinically-evident facial acne.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Key exclusion criteria (14 listed)
- Oral retinoid (Accutane) use within 6 months of entry into the study.
- Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
- Microdermabrasion or superficial chemical peels at the sites to be treated within 2 months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
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 |
|---|---|---|
| V-Beam laser, Candela Corp., 595 nm wavelengthSubjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2. | Device | Laser Therapy |
Primary outcome
Change From Baseline in Papule Acne Lesions at Week 10
Time frame: Baseline and Week 10
Change From Baseline in Pustule Acne Lesions at Week 10
Time frame: Baseline and Week 10
Change From Baseline in Cysts at Week 10
Time frame: Baseline and Week 10
Change From Baseline in Closed Comedones at Week 10
Time frame: Baseline and Week 10
Change From Baseline in Open Comedones at Week 10
Time frame: Baseline and Week 10
Change From Baseline in Erythematous Macules at Week 10
Time frame: Baseline and Week 10
Change From Baseline in Acne Severity at Week 10
Time frame: Baseline and Week 10
The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.
7 secondary outcomes
Change From Baseline in Papule Acne Lesions at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Pustule Acne Lesions at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Cysts at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Closed Comedones at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Open Comedones at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Erythematous Macules at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Acne Severity at Week 16
Time frame: Baseline and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John J Voorhees, MD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V-Beam laser, Candela Corp., 595 nm wavelength in people with Acne Vulgaris, run by University of Michigan at 1 site in United States.
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 5 inclusion and 14 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 18 Oct 2016. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Papule Acne Lesions at Week 10 (time frame: Baseline and Week 10). The study lists 7 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 18 Oct 2016.