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

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ClinicalTrials.gov Identifier: NCT02431494
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Nova Southeastern University

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Acne Device: Blue light phototherapy Device: Microcurrent therapy Device: Combination of BLP and Microcurrent Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Preliminary Efficacy of Combination Blue Light Phototherapy and Microcurrent Therapy for the Treatment of Acne Vulgaris
Actual Study Start Date : October 30, 2014
Actual Primary Completion Date : May 12, 2017
Actual Study Completion Date : May 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: BLP arm (Blue Light Phototherapy)
In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. 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.
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.

Active Comparator: MCT arm (Microcurrent Therapy)
In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. 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.
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.

Active Comparator: Combination of BLP and Microcurrent
In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. 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.
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.




Primary Outcome Measures :
  1. Change in Number of Acne Lesions over the course of 9 weeks [ Time Frame: Weeks 1,3,5,6,9 ]
    The investigators will conduct a systematic count of acne lesions (papules and pustules) present in all of the affected areas of the face.

  2. Change in the Amount of Sebum Produced over the course of 9 weeks [ Time Frame: Weeks 1,3,5,6,9 ]
    The investigators will use the Sebumeter® SM 815 manufactured by CK Electronic to estimate the amount of sebum. The measurement is based on grease spot photometry. The mat tape of the Sebumeter® SM 815 is brought into contact with facial skin. It becomes transparent in relation to the sebum on the surface of the measurement area. Then the tape is inserted into the aperture of the device and the transparency is measured by a photocell. The light transmission represents the sebum content.

  3. Change in Acne Severity over the course of 9 weeks [ Time Frame: Weeks 1 and 9 ]
    The investigators will use the acne counts and the digital photographs of the affected areas to compute the acne severity level following the procedures established by Hayashi et al. (2008). The investigators will not print the digital photographs. The investigators will visually inspect the digital photographs and assign a preliminary severity score to each half of the face using the following classification guide: 0-5 papules and/pustules for mild acne; 6-20 for moderate acne, 21-50 for severe acne; and more than 50 for very severe. The investigators will examine each half of the face separately. The most severe classification obtained for either side of the face will be the assigned severity score.

  4. Change in Dermatologic Quality of Life over the course of 9 weeks [ Time Frame: Weeks 1,3,5,6,9 ]
    The investigators will use the Dermatology Life Quality Index (DLQI) developed by A. Y. Finlay and G. K. Khan (1992), one of the most widely used, dermatologic specific quality of life measures in the published literature to assess quality of life. The DLQI consists of 10 Likert type items; 9 of these items have 4 response categories scored from 0 to 3 with "very much" being "3" to "not at all" being "0". Item 7 "Over the last week, has participant's skin prevented participant from working or studying" uses dichotomous responses; where "yes" is scored as a "3" and a "no" requires answering an additional sub-question, "Over the past week how much has participant's skin been a problem at work or studying". Responses for this sub-question range from "a lot" coded a "2", to "not at all" coded a "0." The DLQI is calculated by summing the response to each question; the maximum score is "30" and the minimum score is "0". The higher the score, the lower the dermatologic quality of life.


Secondary Outcome Measures :
  1. Change in Social Anxiety Score over the course of 9 weeks [ Time Frame: Weeks 1 and 9 ]
    Symptoms of social anxiety will be assessed using the Liebowitz Social Anxiety Scale (Liebowitz, 1987), one of the most widely used scales to measure social anxiety. It consists of 24 items designed to assess fear and avoidance in different situations that are likely to produce social anxiety such as going to a party or speaking in public. For each situation, participants are first asked to state how fearful or anxious they feel in that situation using a Likert scale that ranges from "none" (0) to "severe" (3). Then they are asked to state how often they avoid that same situation using a Likert scale that ranges from "never" (0) to "usually" (3). Responses are summed to create an overall anxiety score.

  2. Change in Depressive Symptomatology Score over the course of 9 weeks [ Time Frame: Weeks 1 and 9 ]
    The investigators will assess depressive symptomatology using the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983), one of the most widely used screening tools to identify symptoms of depression, anxiety and emotional distress amongst patients being treated for a variety of clinical problems. It consists of 14 items, 7 of which assess generalized symptoms of anxiety and the remaining 7 assess depressive symptomatology. Although the specific wording of the item responses vary in accordance to the item, all responses are coded using a Likert format ranging from "0" to "3" where the most positive response is coded a "0" and the most negative response a "3". The maximum score for each subscale is 21; higher scores are reflective of more symptoms of anxiety or depression.

  3. Change of Self-esteem Score over the course of 9 weeks [ Time Frame: Weeks 1 and 9 ]
    Self-esteem will be assessed using the Rosenberg Self-Esteem Scale, one of the most widely-used self-esteem measures in social science research. It consists of ten items designed to assess respondent's self-satisfaction, self-respect and other general feelings about himself/herself. The response format is a four point Likert scale ranging from "strongly agree" to "strongly disagree". For items 1, 2, 4, 6, 7: Strongly Agree=3, Agree=2, Disagree=1, and Strongly Disagree=0. For items 3, 5, 8, 9, 10: Strongly Agree=0, Agree=1, Disagree=2, and Strongly Disagree=3. The scale ranges from 0-30, higher scores indicating higher self-esteem.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431494


Locations
United States, Florida
NSU COM Division of Dermatology, General, Cosmetic Dermatology and Cutaneous Surgery
Fort Lauderdale, Florida, United States, 33328
Hollywood Dermatology
Hollywood, Florida, United States, 33021
Sponsors and Collaborators
Nova Southeastern University
Investigators
Principal Investigator: Sergey Arutyunyan, M.S. Nova Southeastern University College of Osteopathic Medicine

Publications:
Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02431494     History of Changes
Other Study ID Numbers: 08291420Exp
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: April 2016

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases