Acne Clinical Trial
Official title:
"A Randomized, Controlled, Evaluator-blinded Pilot Study to Evaluate the Effect of Automated Text Message Reminders on Patient Compliance With Topical Medications and Its Efficacy on Skin Disease Control in Adolescents and Adults With Mild to Moderate Acne"
The purpose of this study is to determine whether an automated electronic reminder system
using text messages sent to patient's cell phones will help patients with acne be more
compliant with their topical medications and lead to an improvement of their acne.
Hypothesis: Automatically delivered electronic reminders in the form of text messages will
increase acne patient adherence to topical medications and consequently result in better
treatment outcome and higher patient satisfaction
Patient non-compliance with topical medication use is a significant determinant of treatment
failure resulting in both patient and physician frustration with outcome and leading to
suboptimal medical care. It is important to address ways to improve patient compliance both
from a medical and economic standpoint, as adequate use of medications could lead to a
reduction of unnecessary office visits and a more cost-effective use of prescribed
medications.
Patients with mild to moderate acne will be prescribed a standard treatment regimen with
clindamycin/benzoyl peroxide gel in the mornings and adapalene gel in the evenings. Half of
the subjects will then be randomly assigned to receive customized text messages instructing
them twice a day to apply their morning and evening cream as prescribed, with the remainder
of subjects serving as controls. Each medication tube supplied to every subject will be
fitted with an electronic Medication Event Monitoring System cap (MEMS cap) which has the
ability to record the date and time of every opening/closing of the tube. This data will
serve as an objective measure of medication use and will be used to determine whether the
reminder messages resulted in a higher and more consistent use of the prescribed medications.
Specific Aims:
The primary aim of the study is to determine whether automated text messages produce
increased adherence with medication use in the Reminder group compared to the Control group
over the 12 week study duration.
Improvement in acne will be measured using full face lesion counts, Investigator Global
Assessment Score (IGA) and subject Global Assessment Score (SGA). Quality of life and
satisfaction will be measured using the Dermatology Life Quality Index (DLQI), and patient
satisfaction surveys.
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