Experience With Topical Acne Treatment

Study Overview
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Brief Summary
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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

Official Title
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Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications

Conditions
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Acne

Intervention / Treatment
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* Drug: Adapalene Gel
* Drug: Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel
* Drug: adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥18 years of age Patients with a current diagnosis of acne Patients who live in the US, Patients have sufficient command of the English language Exclusion Criteria: Patients less than the age of 18 Patients without a current diagnosis of acne Patients who do not live in the US Patients without a sufficient command of the English language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One gel treatment<br>Every participant will be instructed to apply a topical retinoid every day. | Drug: Adapalene Gel<br>* Single topical treatment arm topical to be applied daily to area affected<br>* Other names: Differin;|
| Experimental: Two gel treatment<br>One-third of the participants will be instructed to apply adapalene and the clindamycin phosphate/benzoyl peroxide gel every day. | Drug: Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel<br>* Two topical treatments will be dispensed and instructions to apply daily to affected area<br>* Other names: Differin and ONEXTON;|
| Experimental: Three gel treatment<br>One-third of the participants will be instructed to apply adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day. | Drug: adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.<br>* Three topical treatments will be dispensed and instructions to apply daily to affected area arm.<br>* Other names: Differin, Epsolay, Clindamycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached | End of study visit - day 56 | 
| Medication Adherence | Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened | End of study visit - day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender specific adherence (female subjects) | Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome | End of study visit - day 56 | 
| Gender specific adherence (male subjects) | Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome | End of study visit - day 56 |