Clinical trial NCT03707236: The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin
Official title: The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: Isotretinoin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The role of telemedicine in dermatology is ever-expanding. Currently, teledermatology has been shown to be advantageous in disease processes that require frequent office follow-up visits such as psoriasis. In 2010, Watkins et al. demonstrated that teledermatology was effective in treating patients 16 years and older with moderate acne and demonstrated equivocal clinical outcomes as traditional office visits along with equivocal patient and provider satisfaction scores. More recently, Fruhauf et al. conducted a small study examining patients with severe acne on isotretinoin and found similar results in terms of safety and efficacy. Patients with severe acne on isotretinoin therapy currently are scheduled for monthly office visits in the dermatology clinic for at least six consecutive months during which time the severity of their acne is assessed by a dermatologist and dose adjustments are made accordingly. Patients are also required to get monthly laboratory studies immediately before, during, or after their visit, and this must be reviewed by the provider prior to prescription renewal according to iPledge guidelines. Given the fact that this medication is typically prescribed to teenagers or young adults, the high frequency of office visits put a significant burden on both patients and their families and results in unnecessary time missed from work or school.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in total inflammatory lesion count
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Changes in acne severity
timeFrame: Up to 24 weeks
measure: Patient satisfaction
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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