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Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser

This study has been completed.
Sponsor:
Collaborator:
Candela Corporation
Information provided by:
Skincare Physicians of Chestnut Hill
ClinicalTrials.gov Identifier:
NCT00306371
First received: March 22, 2006
Last updated: NA
Last verified: July 2004
History: No changes posted
  Purpose

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


Condition Intervention
Acne
Acne Scars
 Device: 1450nm diode laser

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser

Resource links provided by NLM:

MedlinePlus related topics: Acne Scars
U.S. FDA Resources

Further study details as provided by Skincare Physicians of Chestnut Hill:

Estimated Enrollment: 15
Study Start Date: July 2004
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306371

Locations
United States, Massachusetts
Skincare physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Skincare Physicians of Chestnut Hill
Candela Corporation
Investigators
Principal Investigator: Nathan S Uebelhoer, DO Skincare Physicians of Chestnut Hill
Study Director: Jeffrey S Dover, MD Skincare Physicians of Chestnut Hill
Study Chair: Kenneth A Arndt, MD Skincare Physicians of Chestnut Hill
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306371     History of Changes
Other Study ID Numbers: 20040308, WIRB study # 1056817
Study First Received: March 22, 2006
Last Updated: March 22, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Skincare Physicians of Chestnut Hill:
diode
laser
acne
acne scar

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
 Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013