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

Stopped early · Not applicable

Conditions studied: Acne Vulgaris, Acne

In brief

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.

Key facts

Study ID: NCT02431494
Run by: Nova Southeastern University
People needed: 4
Starts: 2014-10-30
Expected to finish: 2017-05-12
Last updated by the study team: 2020-02-24

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have mild to moderate facial acne
Have Fitzpatrick skin type II-V
Be able to understand written and/or spoken English
Be able to provide written informed consent.

You may not qualify if…

Have been treated with oral retinoids in the past 6 months
Have been treated with oral antibiotic within the last 30 days
Have received topical acne treatment (i.e. retinoids, antibiotics and anti-inﬂammatory agents or chemical peeling) within the last 30 days
Pregnant or lactating
Have history of photo-sensitive dermatitis
Have previously received light therapy
Taking oral contraceptive pills (OCP)
Have pacemaker

Where it is running

NSU COM Division of Dermatology, General, Cosmetic Dermatology and Cutaneous Surgery — Fort Lauderdale, Florida, United States
Hollywood Dermatology — Hollywood, Florida, United States

Full record on ClinicalTrials.gov

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