Acne | "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"
Acne research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Text message remindersSubjects in this arm will receive twice daily automated text messages reminding them to apply their medications.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Text message reminders
Start Date: February 2010
Completed Date: August 2010
Primary Outcome: adherence to topical medication use
Secondary Outcome: Improvement in acne severity (as measured by IGA score)
Study sponsors, principal investigator, and references
Lead Sponsor: University of Texas Southwestern Medical Center
Collaborator: University of California, Davis