Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris

Summary

Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in visible lesions that can be quite disfiguring. Consequently, individuals with acne often suffer from a wide range of psychological manifestations. Although there is consensus that combination therapy is most effective in treating acne, researchers are constantly striving to develop new treatment. Microcurrent therapy (MCT) is a non-invasive modality that has successfully been used to promote wound healing and has been routinely used in aesthetics. Use of MCT alone or in combination with current successful treatment such as blue light phototherapy (BLP), may hold promise for acne treatment. The investigators propose to conduct a small randomized control trial to determine the safety and preliminary efficacy of a novel combination therapy to treat acne vulgaris. The investigators will recruit up to 60 males and females and randomly assign them to one of 3 arms: 1) BLP; 2) MCT; and combination therapy (BLP and MCT). The investigators will assess physiological parameters (number of acne lesions, amount of sebum produced, degree of acne severity) and psychosocial factors (dermatologic quality of life, social anxiety, depressive symptomatology, self-esteem). Participants will complete a baseline assessment prior to initiating treatment and a follow-up assessment at 4 weeks post termination of treatment. The investigators will conduct intermediary assessments at weeks 3 and 5 and 1 week post termination of the treatment. The investigators will use measures of central tendency to describe the sample and repeated measures analysis of variance to compute the main and interaction effects.

Conditions

• Acne Vulgaris
• Acne

Interventions

DEVICE

Blue light phototherapy

Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes.

DEVICE

Microcurrent therapy

Microcurrent therapy (Micro Current Electro-Device w/gloves and carrying case, SKU:DSE-X1008 Classic Spa Collection) The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. The duration of each session will be approximately 45 minutes.

DEVICE

Combination of BLP and Microcurrent

Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.

Sponsors & Collaborators

• Nova Southeastern University

  lead OTHER

Principal Investigators

• Sergey Arutyunyan, M.S. · Nova Southeastern University College of Osteopathic Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-30

Primary Completion

2017-05-12

Completion

2017-05-12

Countries

• United States

Study Locations