"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"

NCT01082523 | Completed

• 1 other identifier: 2008-AB_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acne; Patient Compliance

Outcome Measures

Primary Outcomes (1)

• adherence to topical medication use

  The primary goal 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. Overall adherence will be calculated as the total number of doses applied (recorded cap opening/closing events) divided by the total number of expected doses applied (twice daily cap opening/closing events) based on the prescribed treatment regimen.

  12 weeks

Secondary Outcomes (1)

• Improvement in acne severity (as measured by IGA score)

  12 weeks

Study Arms (2)

Text message reminders

ACTIVE COMPARATOR

Other: Text message reminders

Control

NO INTERVENTION

Interventions

Text message reminders OTHER

Subjects in this arm will receive twice daily automated text messages reminding them to apply their medications.

Text message reminders

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of California, Davis: collaborator

Study Sites (2)

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, 75390-8802, United States

Location

Department of Dermatology, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Patient Compliance

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

US (2)