NCT02431494

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

Terminated NA Results posted Last updated 24 February 2020

What this trial tests

NA trial testing Blue light phototherapy in Acne Vulgaris in 4 participants. Terminated before completion.

Timeline

30 October 2014

Primary endpoint
12 May 2017

12 May 2017

Quick facts

Lead sponsor	Nova Southeastern University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	30 October 2014
Primary completion	12 May 2017
Estimated completion	12 May 2017
Sites	2 locations across United States

Drugs / interventions tested

• Blue light phototherapy
• Microcurrent therapy
• Combination of BLP and Microcurrent

Conditions studied

• Acne Vulgaris — all drugs for Acne Vulgaris →
• Acne — all drugs for Acne →

Sponsor

Nova Southeastern University

Who can join

Adults 18 to 30, any sex, with Acne Vulgaris or Acne. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Light therapies for acne.
   Barbaric J, Abbott R, Posadzki P, Car M, et al · · 2016 · cited 26× · PMID 27670126 · DOI 10.1002/14651858.cd007917.pub2