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

April 4, 2023 updated by: Daniela Kroshinsky, Massachusetts General Hospital

The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 24 weeks
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.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018P001749

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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