Acne Vulgaris
Conditions
Brief summary
The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically.
Detailed description
We give subjects topical benzoyl peroxide, a standard first line acne treatment, in a container that records when the container is opened and closed. Subjects will simply be asked to return in six weeks to see how well benzoyl peroxide works for them. Subjects initially will not be told that they are participating in a formal study. When they return with their medication, we will seek their informed consent to participate in the study. Verbal consent will be obtained at the beginning of the study. There will be no written consent obtained until the end of the study. By doing this, subjects will not be aware that adherence is being measured. Subjects will not be aware that they are participating in a study. Only if they consent would we then collect the medication container and monitor and retrieve the adherence data. If they do not consent, we will not have collected any research data on them except baseline acne severity measures which may have been collected anyway as part of their clinic treatment.
Interventions
DRUGBenzoyl Peroxide
Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.
Sponsors
Wake Forest University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Any male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist will be eligible for participation. * Verbal 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 should not be using topical retinoids or benzoyl peroxide products, including Proactive® or topical prescription medications for the treatment of acne vulgaris for at least 2 weeks prior to beginning the study. Oral medications for the treatment of acne should not have been used at least 4 weeks prior to beginning 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 weeks | Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Benzoyl Peroxide 5% Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Benzoyl Peroxide 5% |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Adherence
Adherence to medication use as measured by MEMS cap reported as % of prescribed doses actually applied
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Benzoyl Peroxide 5% | Adherence | 46.5 percentage of doses actually applied |