Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne
| Status: | Completed |
|---|---|
| Conditions: | Acne, Acne, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 13 - 18 |
| Updated: | 8/30/2018 |
| Start Date: | July 2006 |
| End Date: | May 2008 |
The purpose of this research study is to see how often benzoyl peroxide is applied for acne.
Use of medication was monitored electronically.
Use of medication was monitored electronically.
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.
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.
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.
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