N/A
N=20
A Novel Method to Improve Acne Outcomes
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01176955 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. — 74; 32 percentage of days containers were open
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet survey (Behavioral); Benzoyl peroxide 5% gel (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Wake Forest University
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. |
74; 32 | — |
| SECONDARY The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. |
-0.71; -0.25 | — |
| SECONDARY The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. |
-36; -8 | — |
| SECONDARY The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment. |
0.53 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01176955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.