Acne Vulgaris
Conditions
Keywords
Acne, Acne vulgaris, Adherence, Compliance, MEMS, Benzoyl peroxide
Brief 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.
Interventions
BEHAVIORALInternet survey
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.
Topical benzoyl peroxide 5% gel, to be used once daily to the face.
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. | Baseline to 12 weeks | 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. |
| The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. | Baseline to 12 weeks | 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. |
| The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment. | 12 weeks | All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Internet Survey Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication. | 10 |
| Control Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Internet Survey | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.5 years STANDARD_DEVIATION 2.22 | 15.3 years STANDARD_DEVIATION 1.49 | 15.4 years STANDARD_DEVIATION 1.85 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Internet Survey | The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. | 74 percentage of days containers were open |
| Control | The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. | 32 percentage of days containers were open |
Secondary
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Survey | The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. | -36 percent change in lesion count | Standard Deviation 37 |
| Control | The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. | -8 percent change in lesion count | Standard Deviation 65 |
Secondary
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Internet Survey | The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. | -0.71 units on a scale | Standard Deviation 0.76 |
| Control | The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. | -0.25 units on a scale | Standard Deviation 0.46 |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Internet Survey | The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment. | 0.53 Spearman's Rank Correlation Coefficient |