Clinical trial NCT02431494: Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris
Official title: Safety and Preliminary Efficacy of Combination Blue Light Phototherapy and Microcurrent Therapy for the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acne Vulgaris
Acne
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Acne Lesions Over the Course of 9 Weeks
timeFrame: Weeks 1,3,5,6,9
measure: Change in the Amount of Sebum Produced Over the Course of 9 Weeks
timeFrame: Weeks 1,3,5,6,9
measure: Change in Acne Severity Over the Course of 9 Weeks
timeFrame: Weeks 1 and 9
measure: Change in Dermatologic Quality of Life Over the Course of 9 Weeks
timeFrame: Weeks 1,3,5,6,9
Secondary outcomes:
measure: Change in Social Anxiety Score Over the Course of 9 Weeks
timeFrame: Weeks 1 and 9
measure: Change in Depressive Symptomatology Score Over the Course of 9 Weeks
timeFrame: Weeks 1 and 9
measure: Change of Self-esteem Score Over the Course of 9 Weeks
timeFrame: Weeks 1 and 9
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: NSU COM Division of Dermatology, General, Cosmetic Dermatology and Cutaneous Surgery
state: Florida
city: Hollywood
country: United States
facility: Hollywood Dermatology
state: Florida
Study officials:
affiliation: Nova Southeastern University College of Osteopathic Medicine
name: Sergey Arutyunyan, M.S.
role: PRINCIPAL_INVESTIGATOR
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