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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306371
• Other study ID #: 20040308
• Secondary ID: WIRB study # 105
• Status: Completed
• Phase: N/A
• First received: March 22, 2006
• Last updated: March 22, 2006
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: July 2004
• Source: Skincare Physicians of Chestnut Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Acne
• Acne Scars
• Acne Vulgaris

Intervention

Device:
• 1450nm diode laser

Locations

Country	Name	City	State
United States	Skincare physicians of Chestnut Hill	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Skincare Physicians of Chestnut Hill	Candela Corporation

Country where clinical trial is conducted

United States,