AcneNCT00306371
Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser
An observational study of Acne and Acne Scars, run by Skincare Physicians of Chestnut Hill at 1 site in United States.
Trial summary
Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Acne Scars
- What is being tested?
- 1450nm diode laser
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Feb 2006
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acne lesion count of at least 10 inflammatory papules on each side of the face and a severity grade consistent with color photographs in the Allen \& Smith grading scale of greater than or equal to grade 3 and no worse than grade 5
Who cannot join
- Exclusion criteria included the use of oral retinoids or systemic corticosteroids within the past 6 months and the use of all prescription topical or systemic anti-acne medications 4 weeks prior to the initiation of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Skincare physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
About this study
Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful
Read the detailed description
Numerous light based therapies are currently being used for the treatment of acne. Non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and improving acne scars. Specifically, the 1450 nm laser has been shown to be quite effective. However, it is associated with considerable pain at higher fluences despite topical anesthetics, especially when treating inflammatory acne. The goal of this study was to determine the possibility of using low fluence settings to treat moderate to severe acne at a more tolerable pain level without compromising treatment effectiveness.
- Conditions
- Acne, Acne Scars
- Being tested
- 1450nm diode laser
- Keywords
- diode, laser, acne, acne scar
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1450nm diode laserDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startJul 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Skincare Physicians of Chestnut Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Candela Corporation
- Investigators
- Nathan S Uebelhoer, DO, Principal investigator, Skincare Physicians of Chestnut HillJeffrey S Dover, MD, Study director, Skincare Physicians of Chestnut HillKenneth A Arndt, MD, Study chair, Skincare Physicians of Chestnut Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306371
- Sponsor's protocol ID
- 20040308
- Other IDs
- WIRB study # 1056817
- Status last verified
- Jul 2004
- First submitted
- 22 Mar 2006
- Last updated
- 23 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser
- ClinicalTrials.gov ID
- NCT00306371
- Acronym / sponsor ID
- 20040308
- Conditions
- Acne, Acne Scars
- Keywords
- diode, laser, acne, acne scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Skincare Physicians of Chestnut HillUniversity, hospital or other
- Collaborators
- Candela Corporation
- Study start
- Jul 2004
- Study completion
- Feb 2006
- First posted
- 23 Mar 2006 (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.
Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful
Detailed description
Numerous light based therapies are currently being used for the treatment of acne. Non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and improving acne scars. Specifically, the 1450 nm laser has been shown to be quite effective. However, it is associated with considerable pain at higher fluences despite topical anesthetics, especially when treating inflammatory acne. The goal of this study was to determine the possibility of using low fluence settings to treat moderate to severe acne at a more tolerable pain level without compromising treatment effectiveness.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acne lesion count of at least 10 inflammatory papules on each side of the face and a severity grade consistent with color photographs in the Allen \& Smith grading scale of greater than or equal to grade 3 and no worse than grade 5
Key exclusion criteria (1 listed)
- Exclusion criteria included the use of oral retinoids or systemic corticosteroids within the past 6 months and the use of all prescription topical or systemic anti-acne medications 4 weeks prior to the initiation of the 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 |
|---|---|---|
| 1450nm diode laser | Device | – |
Primary outcome
Not reported in the source record.
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 23 Mar 2006.
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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.
Nathan S Uebelhoer, DO principal investigator
Skincare Physicians of Chestnut Hill
Jeffrey S Dover, MD study director
Skincare Physicians of Chestnut Hill
Kenneth A Arndt, MD study chair
Skincare Physicians of Chestnut Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne and Acne Scars, run by Skincare Physicians of Chestnut Hill 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 1 inclusion and 1 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 23 Mar 2006. 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.
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.
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 23 Mar 2006.