Acne VulgarisNCT01176955
A Novel Method to Improve Acne Outcomes
A study testing Internet survey and Benzoyl peroxide 5% gel in people with Acne Vulgaris, run by Wake Forest University at 1 site in United States.
Trial summary
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Internet survey and Benzoyl peroxide 5% gel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist.
- written consent of participation must be given by parent or guardian and child.
Who cannot join
- Age less than 13 or greater than 18 years of age.
- Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
- Subjects may not use topical retinoids or other benzoyl peroxide products, including Proactiv® or topical prescription medications while enrolled in the study.
- Women that are actively trying to become pregnant or wish to become pregnant during the time frame the study is to take place will be excluded.
- Subjects will be carefully selected for this study and only those deemed appropriate for treatment with benzoyl peroxide will be placed on this medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: A Novel Method for Improving Acne Outcomes
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.
- Conditions
- Acne Vulgaris
- Being tested
- Internet survey, Benzoyl peroxide 5% gel
- Keywords
- Acne, Acne vulgaris, Adherence, Compliance, MEMS, Benzoyl peroxide
- 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.
Internet surveyBehavioural
A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication.
Benzoyl peroxide 5% gelDrug
Topical benzoyl peroxide 5% gel, to be used once daily to the face.
| Study group | Role | What they receive |
|---|---|---|
| Internet survey | Experimental | Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. Receives: Behavioral: Internet survey; Drug: Benzoyl peroxide 5% gel |
| Control | Placebo comparator | Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Receives: Drug: Benzoyl peroxide 5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.
Measured: 12 weeks
Secondary outcomes (3)
The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.
Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.
Measured: Baseline to 12 weeks
The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.
Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.
Measured: Baseline to 12 weeks
The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.
All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.
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 posted6 Aug 2010 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Study director, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176955
- Sponsor's protocol ID
- IRB00008982
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2010
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method for Improving Acne Outcomes
- ClinicalTrials.gov ID
- NCT01176955
- Acronym / sponsor ID
- IRB00008982
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Acne vulgaris, Adherence, Compliance, MEMS, Benzoyl peroxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 21 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet survey | Experimental | Behavioral: Internet survey, Drug: Benzoyl peroxide 5% gelSubjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. |
| Control | Placebo comparator | Drug: Benzoyl peroxide 5% gelSubjects will receive standard-of-care treatment with the study medication, without internet surveys. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist.
- written consent of participation must be given by parent or guardian and child.
Key exclusion criteria (7 listed)
- Age less than 13 or greater than 18 years of age.
- Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
- Subjects may not use topical retinoids or other benzoyl peroxide products, including Proactiv® or topical prescription medications while enrolled in the study.
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 |
|---|---|---|
| Internet surveyA weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication. | Behavioural | Internet survey |
| Benzoyl peroxide 5% gelTopical benzoyl peroxide 5% gel, to be used once daily to the face. | Drug | Control, Internet survey |
Primary outcome
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.
Time frame: 12 weeks
Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.
3 secondary outcomes
The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.
Time frame: Baseline to 12 weeks
The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.
Time frame: Baseline to 12 weeks
The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven R Feldman, MD, PhD study director
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet survey and Benzoyl peroxide 5% gel in people with Acne Vulgaris, run by Wake Forest University at 1 site 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 2 inclusion and 7 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. (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 16 Aug 2018.