AcneNCT01082523
"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"
A study testing Text message reminders in people with Acne and Patient Compliance, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Acne, Patient Compliance
- What is being tested?
- Text message reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, 75390-8802
Department of Dermatology, University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About 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
Read the detailed description
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.
- Conditions
- Acne, Patient Compliance
- Being tested
- Text message reminders
- Medical subject headings
- Acne Vulgaris, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message remindersOther
Subjects in this arm will receive twice daily automated text messages reminding them to apply their medications.
| Study group | Role | What they receive |
|---|---|---|
| Text message reminders | Active comparator | Not described Receives: Other: Text message reminders |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Improvement in acne severity (as measured by IGA score)
Secondary endpoints include determination of improvement in acne severity, quality of life, and patient satisfaction in the Reminder versus Control group at study completion (week 12 compared to baseline). 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 Acne Quality Index Index(Acne-QoL), and patient satisfaction surveys.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082523
- Sponsor's protocol ID
- 2008-AB_01
- Status last verified
- Sep 2019
- First submitted
- 5 Mar 2010
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01082523
- Acronym / sponsor ID
- 2008-AB_01
- Conditions
- Acne, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message reminders | Active comparator | Other: Text message reminders |
| Control | No intervention | – |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message remindersSubjects in this arm will receive twice daily automated text messages reminding them to apply their medications. | Other | Text message reminders |
Primary outcome
adherence to topical medication use
Time frame: 12 weeks
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.
1 secondary outcome
Improvement in acne severity (as measured by IGA score)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message reminders in people with Acne and Patient Compliance, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to topical medication use (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.