Study of the Use of Low Level Laser Therapy to Reduce Acne
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Evaluate the Efficacy of Low-level Laser Therapy in Reducing Blemishes by Quantifying a Decrease in Signs of Blemishes, Both Non-inflammatory and Inflammatory|
- Grade on the Burton et al. Acne Severity Grade Scale [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.
- Change From Baseline in Inflammatory Lesion Count at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.
- Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.
|Study Start Date:||March 2010|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Erchonia MLS + Erchonia THL
The Erchonia® MLS contains 5 independent diodes: 4 each emitting 17 milliwatt (mW) 635 nanometers (nm) of red laser light and the fifth diode emitting 17 mW, 405 nm of blue laser light.
The Erchonia THL is a single diode pulsed laser that emits 4.9 milliwatts (mW) of red 635 nanometer (nm) light.
Device: Erchonia MLS + Erchonia THL
The Erchonia® MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Administration of the MLS and the THL occur simultaneously over the 6-week administration phase.
The intent is to evaluate the effectiveness of Erchonia MLS & Erchonia THL when administered together, and not to compare Erchonia MLS vs. Erchonia THL
Acne is a chronic inflammatory disorder plaguing the sebaceous follicle, and debate still remains over what truly initiates lesion formation. Experts agree that an increase in androgen production plays a significant role in the onset of acne. Androgens promote the increase in size of sebaceous glands and stimulate sebum production. The simple act of sebaceous gland stimulation via androgens could ultimately promote the upregulation of pro-inflammatory cytokines like tumor necrosis factor-α (TNF-α) and interleukin (IL-1α) without propionibacteria even being present. The synthesis of IL-α and other pro-inflammatory cytokines including prostaglandins occurs via the inducible enzyme known as cyclooxygenase-2 (COX-2). Studies analyzing the pathogenesis of mucositis have identified COX-2 as an important contributor to the upregulation of pro-inflammatory cytokines and thus a major contributor to the progression of the disorder itself.
Recent evidence indicates that low-level laser therapy (LLLT) is able to significantly diminish the expression of COX-2, resulting in the reduction of inflammation. The ability to modulate the COX-2 pathways via LLLT is believed to inhibit the production of pro-inflammatory cytokines (i.e. TNF-α and IL- α) present in acne-prone skin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276535
|United States, Texas|
|Austin, Texas, United States, 78746|
|Principal Investigator:||Gregory A Nikolaidis, MD|