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Trial record 36 of 163 for:    ISOTRETINOIN

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

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ClinicalTrials.gov Identifier: NCT03707236
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Daniela Kroshinsky, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Behavioral: Teledermatology visits Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial
Estimated Study Start Date : October 18, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Treatment arm
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
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.

No Intervention: Control arm
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.



Primary Outcome Measures :
  1. Change in total inflammatory lesion count [ Time Frame: Up to 24 weeks ]
    Lesion counting involves counting the number of inflammatory lesions on the face, chest, or back. This excludes comedonal acne.


Secondary Outcome Measures :
  1. Changes in acne severity [ Time Frame: Up to 24 weeks ]
    The Leeds scale will be used to assess patients' acne, which examines the extent of inflammation, range and size of inflamed lesions, and associated erythema. The Leeds technique is a counting system for detailed work in therapeutic trials. A scale of 0 (no acne) to 10 (most severe) is used for grading.

  2. Patient satisfaction [ Time Frame: Up to 24 weeks ]
    This will be assessed by having the patient fill out a survey about how much time they missed and costs they may have incurred to go to the appointment. They will also be asked questions about how they feel their acne has affected their lives.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03707236


Contacts
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Contact: Daniela Kroshinsky, MD, MPH (617) 643-3884 dkroshinsky@partners.org

Sponsors and Collaborators
Massachusetts General Hospital

Publications:
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.

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Responsible Party: Daniela Kroshinsky, Director of Inpatient Dermatology, Associate Professor of Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03707236     History of Changes
Other Study ID Numbers: 2018P001749
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Daniela Kroshinsky, Massachusetts General Hospital:
Isotretinoin
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Isotretinoin
Dermatologic Agents