Clinical trial NCT01276535: Study of the Use of Low Level Laser Therapy to Reduce Acne
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* signed informed consent form.
* male or female.
* 18 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.

Exclusion Criteria:

* 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.
* substance abuse (drug or alcohol) problem within the previous 3 years.
* developmental disability or cognitive impairment that may preclude study compliance.
* unlikely to comply with the study protocol and procedure administration protocol, or is considered unsuitable for participation in the study for any other reason in the opinion of the investigator.

Primary outcomes:
measure: Grade on the Burton et al. Acne Severity Grade Scale
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change From Baseline in Inflammatory Lesion Count at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Westlake Dermatology
state: Texas
Study officials:
name: Gregory A Nikolaidis, MD
role: PRINCIPAL_INVESTIGATOR
References: