Study of the Use of Low Level Laser Therapy to Reduce Acne

NCT01276535 | Completed Results

• 1 other identifier: ECACNEP1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of acne blemishes.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Grade on the Burton et al. Acne Severity Grade Scale

  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.

  baseline and 6 weeks

Secondary Outcomes (2)

• Change From Baseline in Inflammatory Lesion Count at 6 Weeks

  Baseline and 6 weeks

• Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks

  Baseline and 6 weeks

Study Arms (1)

Erchonia MLS + Erchonia THL

EXPERIMENTAL

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

Interventions

Erchonia MLS + Erchonia THL DEVICE

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

Erchonia MLS + Erchonia THL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• signed informed consent form.
• male or female.
• to 40 years.
• area sought for acne reduction is the face.
• diagnosis of moderate or severe acne vulgaris, defined as grade 3-5 according to the grading criteria of acne severity given by Burton et al.
• Acne has been ongoing for at least 3 months prior to screening and must include inflammatory lesions.
• female using hormonal birth control must have been on a stable dose for at least 3 months prior to screening.
• negative pregnancy test for female subjects, unless the female subject has been surgically sterilized.
• sexually active female subject who is not surgically sterile or 2 years post menopausal must agree to use approved contraception/birth control measure while on study
• PI (A normal healthy patient) or P2 (A patient with mild systemic disease) on the American Society of Anesthesiologists (ASA) Physical Status Classification System.
• subject agrees to abstain from use of non-study treatments for acne while enrolled in the study.
• subject agrees to abstain from use of tanning beds/sunbathing while partaking in the study.
• subject agrees, and be able, to maintain regular medication schedule, as is medically feasible, during study participation.
• subject agrees to not change skin care regimen throughout study participation.
• subject is willing and able to comply with all requirements of the study protocol.

You may not qualify if:

• use of topical acne treatment within 15 days prior to start of study.
• use of oral acne treatment within 30 days prior to the start of study.
• use of oral isotretinoin or other systemic retinoids in the 12 months preceding the start of the study.
• use of systemic steroids within 30 days prior to the start of the study.
• pregnancy or currently nursing, or planning pregnancy during the course of the study
• participation in any clinical study involving an investigational product within 30 days of the start of the study
• use of tanning beds or sunbathing in the 30 days prior to the start of the study.
• history of keloids or other photosensitive disorders or use of any photosensitizing medication.
• currently taking any medication that may alleviate or exacerbate acne.
• Porphyria or known allergies to porphyrins.
• current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
• known malignancy or history of malignancy other than non-melanoma skin cancer
• human immunodeficiency virus (HIV), hepatitis B or hepatitis C
• signs of bacterial, fungal or viral skin lesions that may interfere with assessment of acne vulgaris.
• known inherited or acquired coagulation defects.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Westlake Dermatology

Austin, Texas, 78746, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Gregory A. Nikolaidis, MD
• Organization: Westlake Dermatology

karen@westlakedermatology.com

512-328-3376

Study Officials

• Gregory A Nikolaidis, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 13, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

US (1)