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

NCT ID: NCT02431494

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-30
• Study Completion Date: 2017-05-12

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.

Conditions

Acne Vulgaris; Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Blue light phototherapy

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Microcurrent therapy

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Combination of BLP and Microcurrent

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey Arutyunyan, M.S.

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University College of Osteopathic Medicine

Locations

NSU COM Division of Dermatology, General, Cosmetic Dermatology and Cutaneous Surgery

Fort Lauderdale, Florida, United States

Hollywood Dermatology

Hollywood, Florida, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 20367674 (View on PubMed)

Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, Shalita AR, Thiboutot D; Global Alliance to Improve Outcomes in Acne. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003 Jul;49(1 Suppl):S1-37. doi: 10.1067/mjd.2003.618. No abstract available.

Reference Type: BACKGROUND

PMID: 12833004 (View on PubMed)

Cunliffe WJ. The sebaceous gland and acne--40 years on. Dermatology. 1998;196(1):9-15. doi: 10.1159/000017859. No abstract available.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 12589953 (View on PubMed)

Cheng N, Van Hoof H, Bockx E, Hoogmartens MJ, Mulier JC, De Dijcker FJ, Sansen WM, De Loecker W. The effects of electric currents on ATP generation, protein synthesis, and membrane transport of rat skin. Clin Orthop Relat Res. 1982 Nov-Dec;(171):264-72.

Reference Type: BACKGROUND

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Bach S, Bilgrav K, Gottrup F, Jorgensen TE. The effect of electrical current on healing skin incision. An experimental study. Eur J Surg. 1991 Mar;157(3):171-4.

Reference Type: BACKGROUND

PMID: 1678624 (View on PubMed)

Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.

Reference Type: BACKGROUND

PMID: 3893385 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

08291420Exp

Identifier Type: -

Identifier Source: org_study_id