The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin

NCT03707236 | Withdrawn

• 1 other identifier: 2018P001749
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Males and females 16 years or older will be randomized to either the control arm (monthly office visits during treatment weeks 8-20) or treatment arm (teledermatology visits during treatment weeks 8-20). The primary outcome is the change in total inflammatory lesion count. Secondary outcomes include changes in acne severity based on the Leeds scale, patient satisfaction, acne severity as perceived by the patient, cost and time-lost to patients and families, need for interim and unexpected urgent appointments, adverse medication effects. The investigators are hypothesizing that patients randomized to the treatment arm will have no statistically significant difference in total inflammatory lesion count or acne severity than the control arm. The investigators also hypothesize that adverse events will be equivalent in both groups and the treatment arm will report less cost associated with visits.

Conditions

Acne Vulgaris

Keywords

Isotretinoin

Outcome Measures

Primary Outcomes (1)

• Change in total inflammatory lesion count

  Lesion counting involves counting the number of inflammatory lesions on the face, chest, or back. This excludes comedonal acne.

  Up to 24 weeks

Secondary Outcomes (2)

• Changes in acne severity

  Up to 24 weeks

• Patient satisfaction

  Up to 24 weeks

Study Arms (2)

Treatment arm

EXPERIMENTAL

Patients in the treatment arm will have monthly office visits for weeks 0-4 and then have monthly teledermatology visits during weeks 8-20 with a final office visit at week 24. Standardized baseline photographs including 3 facial images (front, left, and right) as well as 2 truncal images of the chest and back (if affected) will be taken in the office at treatment week 0 and 24 for all patients. All patients will be required to take photos in front of a white wall to facilitate blinding.

Behavioral: Teledermatology visits

Control arm

NO INTERVENTION

Patients in the control arm will have the same series of photographs taken at each monthly visit. These patients will also be required to fill out a monthly survey assessing acne severity, quality of life, cost of attending appointment, time missed from school/work, satisfaction with treatment (only to be reviewed by study staff) and will be screened for adverse events by their provider. Every patient will be counseled about isotretinoin and contraception (if applicable) by their provider in order to adhere with iPledge requirements. All photographs will be uploaded into the patient's medical record. The physician will be required to document a progress note in the electronic medical record after each visit as per standard hospital protocol.

Interventions

Teledermatology visits BEHAVIORAL

Patients in the treatment arm will be taught by study staff how to take the standardized photos of themselves at treatment week 4 (prior to initiation of teledermatology visits). For patients in the treatment arm, the teledermatology visits will be managed by the study staff. A monthly teledermatology visit will consist of sending facial and truncal (if affected) clinical images to a the study staff using Patient Gateway. Once this is completed, the patient and a member of the study staff will have a scheduled telephone appointment during which the provider will screen for any adverse events and will provide counseling as outlined in iPledge guidelines. The patient will also be asked to verbally complete a monthly survey assessing acne severity, quality of life, cost attributable to the appointment, time missed from school/work, satisfaction with treatment. All photographs will be uploaded in LMR/EPIC in the patient's medical record.

Treatment arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of severe acne by a dermatologist with a plan of initiating treatment with isotretinoin
• Patients must first be enrolled in iPledge prior to eligibility

You may not qualify if:

• Patients who have baseline hepatic dysfunction or hypertriglyceridemia
• Patients with a history of depression, suicide attempts or suicidal ideation
• Patients without access to internet or a camera (including portable camera and/or smart phone) at home
• Patients who are pregnant - absolute contraindication

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (10)

• Koller S, Hofmann-Wellenhof R, Hayn D, Weger W, Kastner P, Schreier G, Salmhofer W. Teledermatological monitoring of psoriasis patients on biologic therapy. Acta Derm Venereol. 2011 Oct;91(6):680-5. doi: 10.2340/00015555-1148.

  PMID: 21879250 BACKGROUND

• Watson AJ, Bergman H, Williams CM, Kvedar JC. A randomized trial to evaluate the efficacy of online follow-up visits in the management of acne. Arch Dermatol. 2010 Apr;146(4):406-11. doi: 10.1001/archdermatol.2010.29.

  PMID: 20404229 BACKGROUND

• Fruhauf J, Krock S, Quehenberger F, Kopera D, Fink-Puches R, Komericki P, Pucher S, Arzberger E, Hofmann-Wellenhof R. Mobile teledermatology helping patients control high-need acne: a randomized controlled trial. J Eur Acad Dermatol Venereol. 2015 May;29(5):919-24. doi: 10.1111/jdv.12723. Epub 2014 Sep 26.

  PMID: 25258175 BACKGROUND

• Risk evaluation and mitigation strategy (REMS). iPLEDGE Program: Single Shared System for Isotretinoin. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforP atientsandProviders/UCM234639.pdf . Accessed November 11, 2012.

  BACKGROUND

• Lucky AW, Barber BL, Girman CJ, Williams J, Ratterman J, Waldstreicher J. A multirater validation study to assess the reliability of acne lesion counting. J Am Acad Dermatol. 1996 Oct;35(4):559-65. doi: 10.1016/s0190-9622(96)90680-5.

  PMID: 8859284 BACKGROUND

• Bergman H, Tsai KY, Seo SJ, Kvedar JC, Watson AJ. Remote assessment of acne: the use of acne grading tools to evaluate digital skin images. Telemed J E Health. 2009 Jun;15(5):426-30. doi: 10.1089/tmj.2008.0128.

  PMID: 19548822 BACKGROUND

• Burke BM, Cunliffe WJ. The assessment of acne vulgaris--the Leeds technique. Br J Dermatol. 1984 Jul;111(1):83-92. doi: 10.1111/j.1365-2133.1984.tb04020.x.

  PMID: 6234917 BACKGROUND

• Lee YH, Scharnitz TP, Muscat J, Chen A, Gupta-Elera G, Kirby JS. Laboratory Monitoring During Isotretinoin Therapy for Acne: A Systematic Review and Meta-analysis. JAMA Dermatol. 2016 Jan;152(1):35-44. doi: 10.1001/jamadermatol.2015.3091.

  PMID: 26630323 BACKGROUND

• Suneja T, Smith ED, Chen GJ, Zipperstein KJ, Fleischer AB Jr, Feldman SR. Waiting times to see a dermatologist are perceived as too long by dermatologists: implications for the dermatology workforce. Arch Dermatol. 2001 Oct;137(10):1303-7. doi: 10.1001/archderm.137.10.1303.

  PMID: 11594853 BACKGROUND

• Tsang MW, Resneck JS Jr. Even patients with changing moles face long dermatology appointment wait-times: a study of simulated patient calls to dermatologists. J Am Acad Dermatol. 2006 Jul;55(1):54-8. doi: 10.1016/j.jaad.2006.04.001. Epub 2006 May 6.

  PMID: 16781292 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Inpatient Dermatology, Associate Professor of Dermatology

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 16, 2018
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04