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

Overview: The goal of this study is to conduct a small randomized control trial (RCT) to test
the safety and preliminary efficacy of a novel combination therapy to treat acne vulgaris.
The investigators will also explore the effects of the treatments on psychosocial factors
(Dermatology Life Quality Index (DLQI), social anxiety, depressive symptomatology, and
self-esteem). The RCT will have 3 arms: 1) FDA approved treatment: blue light phototherapy
(BLP); 2) Microcurrent therapy (MCT); and 3) combination therapy (BLP + MCT). The main
outcomes will be: 1) number of acne lesions; 2) amount of sebum produced, 3) degree of acne
severity; and 4) improvement in dermatologic quality of life. The specific aims of the study
are:

Aim 1: To explore the use of MCT to improve blood flow and lymphatic drainage and promote
tissue repair in patients with acne vulgaris.

Aim 2: To examine the safety and preliminary efficacy of enhancing traditional blue light
therapy treatment with microcurrent therapy (BLP + MCT) to promote faster healing in patients
with acne vulgaris.

Aim 3: To determine if combination therapy is a more effective (fewer number of acne lesions,
decreased amount of sebum produced, lesser degree of acne severity and greater improvement in
dermatologic quality of life) for acne than either type of monotherapy.

Aim 4: To explore the effects of the three modalities on psychosocial factors (social
anxiety, depressive symptomatology, and self-esteem).

The investigators will recruit up to 60 males and females and randomly assign them to one of
3 treatment arms (blue light phototherapy (BLP); microcurrent therapy (MCT); and combination
therapy (BLP and MCT). All participants will complete a baseline assessment prior to
initiating treatment one follow-up assessment at 4 weeks post termination of treatment.
During the treatment phase, the investigators will conduct intermediary assessments to track
the progression of the treatment over time at weeks 3 and 5 as well as 1 week post the
termination of the treatment (week 6). The investigators will conduct both physiological and
psychosocial assessments; the content of the intermediary assessment will be much less than
the other 3 assessments to reduce participant data. The most comprehensive assessments will
be conducted at baseline and one follow-up points and will consist of all of the
physiological and psychosocial factors as well as demographic factors that will be collected
exclusively at the baseline assessment. At the intermediary assessments, the investigators
will collect the number of acne lesions, amount of sebum produced and dermatologic quality of
life. Psychosocial data will be collected via computer-assisted self-interviews (CASI).
Physiological data will be entered into the computer program by research staff.

Procedures for collecting psychosocial data: All assessments will be conducted using
computer-assisted self-interviews (CASI). Participants will be assigned a unique study
identification number (ID) that will be used to track data. Computer-assisted self-interviews
are more effective than other tools for measuring sensitive and socially stigmatized
behaviors. This mode of data collection eliminates interviewer bias, standardizes
questionnaire administration, and reduces skip pattern errors. Using CASI, the participant
responds to the questions using the computer keyboard or mouse. Selection of CASI for data
collection decreases costs and error of entry, cleaning data, and publication lag, as well as
enhances interviewer efficiency. The laptop computers the investigators use for data
collection have been set up with two different log-in screens, one for participants and one
for an administrator. The screen used by participants only contains the icon to access the
CASI system. No other files appear or are available on this screen. The investigators access
the CASI for participants by clicking the icon and filling in the assigned participant ID
number (not participant name) completing all set up procedures. The investigator then
provides a brief training on using the laptop and completing the CASI. As part of this
training, the participant will complete a brief set of practice questions illustrative of the
type of questions and the responses contained in the assessment. The investigator remains
with the participant during the practice session to answer questions or to provide additional
instructions. Participants will be encouraged to seek assistance, if needed, as they complete
the interview. At this point, the interview starts and the participant completes the
interview on their own. Once the participant completes the interview, he/she comes upon a
screen instructing him/her to contact the investigators so that the file may be saved
correctly.

Procedures for collecting physiological data: The investigators will conduct visual
inspection of the affected areas and systematically count the number of acne lesions present
on the face. At baseline and the follow-up assessment the investigators will also take high
quality digital photographs of the affected areas that will be used to compute the degree of
acne severity. The photographs will be identified exclusively by study ID and will be kept in
a password protected file in a secure NSU computer. The Sebumeter® SM 815 sebum meter will be
used to estimate the amount of sebum produced. The investigators will bring the mat tape of
the meter in contact with the affected areas. This instrument uses a non-invasive probe
placed on the affected area and the instrument then calculates the amount of sebum produced.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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