Acne
Conditions
Brief summary
Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2
Interventions
DRUGclindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel
Single topical treatment to be applied daily to area affected once daily.
DRUGadapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel
Two topical treatments to be applied to area affected once daily.
DRUGCompounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel
Three topical treatments to be applied to area affected once daily.
Sponsors
Bausch Health Americas, Inc.
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients ≥18 years of age 2. Patients with a current diagnosis of acne 3. Patients who live in the US, 4. Patients have sufficient command of the English language
Exclusion criteria
1. Patients less than the age of 18 2. Patients without a current diagnosis of acne 3. Patients who do not live in the US 4. Patients without a sufficient command of the English language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | End of study visit - day 56 | Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gender specific adherence (female subjects) | End of study visit - day 56 | Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome |
| Gender specific adherence (male subjects) | End of study visit - day 56 | Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome |
Countries
United States
Outcome results
None listed