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

NCT02431494 | Terminated Results

• 1 other identifier: 08291420Exp
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris; Acne

Outcome Measures

Primary Outcomes (4)

• Change in Number of Acne Lesions Over the Course of 9 Weeks

  The investigators will conduct a systematic count of acne lesions (papules and pustules) present in all of the affected areas of the face.

  Weeks 1,3,5,6,9

• Change in the Amount of Sebum Produced Over the Course of 9 Weeks

  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.

  Weeks 1,3,5,6,9

• Change in Acne Severity Over the Course of 9 Weeks

  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.

  Weeks 1 and 9

• Change in Dermatologic Quality of Life Over the Course of 9 Weeks

  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.

  Weeks 1,3,5,6,9

Secondary Outcomes (3)

• Change in Social Anxiety Score Over the Course of 9 Weeks

  Weeks 1 and 9

• Change in Depressive Symptomatology Score Over the Course of 9 Weeks

  Weeks 1 and 9

• Change of Self-esteem Score Over the Course of 9 Weeks

  Weeks 1 and 9

Study Arms (3)

BLP arm (Blue Light Phototherapy)

ACTIVE COMPARATOR

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

MCT arm (Microcurrent Therapy)

ACTIVE COMPARATOR

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

Combination of BLP and Microcurrent

ACTIVE COMPARATOR

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

Interventions

Blue light phototherapy 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.

BLP arm (Blue Light Phototherapy)

Microcurrent therapy 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.

MCT arm (Microcurrent Therapy)

Combination of BLP and Microcurrent 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.

Combination of BLP and Microcurrent

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (2)

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

Fort Lauderdale, Florida, 33328, United States

Location

Hollywood Dermatology

Hollywood, Florida, 33021, United States

Location

Related Publications (8)

• Uhlenhake E, Yentzer BA, Feldman SR. Acne vulgaris and depression: a retrospective examination. J Cosmet Dermatol. 2010 Mar;9(1):59-63. doi: 10.1111/j.1473-2165.2010.00478.x.

  PMID: 20367674 BACKGROUND

• 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.

  PMID: 12833004 BACKGROUND

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

  PMID: 9557218 BACKGROUND

• Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.

  PMID: 9892952 BACKGROUND

• Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.

  PMID: 12589953 BACKGROUND

• 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.

  PMID: 7140077 BACKGROUND

• 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.

  PMID: 1678624 BACKGROUND

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

  PMID: 3893385 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Sue Breno
• Organization: Nova Southeastern University

sb1382@nova.edu

9542621447

Study Officials

• Sergey Arutyunyan, M.S.

  Nova Southeastern University College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 1, 2015
• Study Start: October 30, 2014
• Primary Completion: May 12, 2017
• Study Completion: May 12, 2017
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)