"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 Acn(Clinical Trial 567168)
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Dallas |
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State:
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TX |
| Zip Code: |
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75390 |
| Conditions: |
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Acne - Patient Compliance |
| Purpose: |
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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
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- males and females 12-30 years of age at time of consent
- any ethnic background
- be capable of giving informed consent
- have clinical diagnosis of acne vulgaris with facial involvement for at least 6
months prior to enrollment.
- Must have a minimum of 30 to 100 non-inflammatory facial lesions (open and/or closed
comedones), and 20 to 50 inflammatory lesions (papules or pustules) and no nodules or
cysts.
- Must have a score 2 or 3 on the Investigator Global Assessment Scale (IGA)
- Must own a personal mobile telephone with SMS text messaging capabilities.
- Must be English or Spanish speaking.
- Women of child bearing potential and all men must be using adequate birth control
measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method
with spermicide, or surgical sterilization) and must agree to continue to use such
measures and not become pregnant or plan a pregnancy until 12 months after receiving
the last dose of study medication.
- Must be able to adhere to study visit schedule and other protocol requirements.
- Must avoid prolonged sun exposure and avoid use of tanning booths or other
ultraviolet light sources during the study.
- Must agree not to use any other prescription or over the counter medications other
than the ones prescribed by the study protocol.
- Must agree to limit Vitamin A supplementation to total daily dose 4000-5000 IU.
Exclusion Criteria:
- Nodular or cystic acne, acne conglobata, acne fulminans, secondary acne (chloracne,
drug-induced, mechanical)
- Known exposure history to environmental or chemical comedogenic agents such as
cutting oils, tar, halogenated compounds or polyaromatic hydrocarbons.
- Women with a known history or clinical evidence of hyperandrogenism such as
polycystic ovarian syndrome.
- Known history or clinical evidence of Cushing's syndrome or congenital adrenal
hyperplasia.
- Use of hormonal contraceptives or intrauterine device (unless subject is on stable
dose, i.e at least 6 months of prior treatment
- Have used any investigational drug within the previous 4 weeks or 5 times the half
life of the investigational drug, whichever longer.
- Have received phototherapy or use a tanning booth within 4 weeks prior to enrollment
- Currently taking any systemic medications that could affect evaluation of acne
(including, but not limited to antibiotics, retinoids, biologic disease modifying
agents, chemotherapeutic agents, anti-epileptic agents or EGFR-receptor antagonists)
- History of chronic or recurrent infectious disease, including, but not limited to
folliculitis, infected skin wounds or ulcers and recurrent herpes simplex infections.
- Known hypersensitivity response, including anaphylaxis, to any of the compounds used
for treatment (e.g: clindamycin, retinoids).
- Known substance abuse (drug or alcohol) problem within the previous 12 months.
- Presence of beard or facial hair which might interfere with study assessments
- Participating in another clinical trial using an investigational agent or procedure
during participation in the study.
- Are pregnant or planning pregnancy or a surgery during the participation in the study |
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| Study is available at: |
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Department of Dermatology, University of Texas Southwestern Medical Center
Dallas, TX 75390
United States
Primary Contact:
Memoree Lee
Email: Memoree.Lee@utsouthwestern.edu
Phone: 214-645-8971
Secondary Contact:
Andreas Boker, M.D
Email: andreasboker@gmail.com
Phone: (214) 645-8971 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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