Experience With Topical Acne Treatment

NCT05582434 — Early Phase 1, Active not recruiting, 72 participants, Wake Forest University Health Sciences

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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

RegistryNCT05582434
StatusActive not recruiting
PhaseEarly Phase 1
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment72 (Actual)
SponsorWake Forest University Health Sciences (Other); collaborators: Bausch Health Americas, Inc.
ConditionsAcne
Interventionsclindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel, adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel, Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel (Drug)
Datesstart 2024-02-15, primary completion 2025-06-19, completion 2026-11-01 (estimated), first posted 2022-10-17, last updated 2025-12-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Acne All trials of clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel All trials of adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel

-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

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+Arms and interventions

ArmTypeInterventionsDescription
One single fixed-combination productExperimentalDrug: clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gelParticipants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily
Two productsExperimentalDrug: adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gelParticipants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily
Three productsExperimentalDrug: Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gelParticipants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily
  • clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel (Drug), also known as Cabtreo®: Single topical treatment to be applied daily to area affected once daily.
  • adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel (Drug), also known as Epiduo® Forte and Clindamycin: 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), also known as Differin®, Epsolay, Clindamycin: Three topical treatments to be applied to area affected once daily.

+Outcome measures

Primary outcomes

  • 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
  • Medication Adherence [End of study visit - day 56]: Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened

Secondary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Locations (1)

FacilityCityCountryStatus
Wake Forest University Health SciencesWinston-Salem, North CarolinaUnited States

+Publications

  • 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. PMID 20618564
  • 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. PMID 27784999
  • 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. PMID 23572294

+Investigators