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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One single fixed-combination product | Experimental | Participants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily |
|
| Two products | Experimental | Participants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily |
|
| Three products | Experimental | Participants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel | Drug | Single topical treatment to be applied daily to area affected once daily. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20618564 | Background | Lott R, Taylor SL, O'Neill JL, Krowchuk DP, Feldman SR. Medication adherence among acne patients: a review. J Cosmet Dermatol. 2010 Jun;9(2):160-6. doi: 10.1111/j.1473-2165.2010.00490.x. | |
| 27784999 | Background | Moradi Tuchayi S, Alexander TM, Nadkarni A, Feldman SR. Interventions to increase adherence to acne treatment. Patient Prefer Adherence. 2016 Oct 11;10:2091-2096. doi: 10.2147/PPA.S117437. eCollection 2016. |
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|
| adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel | Drug | Two topical treatments to be applied to area affected once daily. |
|
|
| Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel | Drug | Three topical treatments to be applied to area affected once daily. |
|
|
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 |
| 23572294 | Background | Tan X, Al-Dabagh A, Davis SA, Lin HC, Balkrishnan R, Chang J, Feldman SR. Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris. Am J Clin Dermatol. 2013 Jun;14(3):243-51. doi: 10.1007/s40257-013-0016-x. |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C007084 | clindamycin phosphate |
| D000068816 | Adapalene |
| D005782 | Gels |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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