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Experience With Topical Acne Treatment

Primary Purpose

Acne

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adapalene Gel
Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel
adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

One gel treatment

Two gel treatment

Three gel treatment

Arm Description

Every participant will be instructed to apply a topical retinoid every day.

One-third of the participants will be instructed to apply adapalene and the clindamycin phosphate/benzoyl peroxide gel every day.

One-third of the participants will be instructed to apply adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.

Outcomes

Primary Outcome Measures

Medication Adherence
Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached
Medication Adherence
Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened

Secondary Outcome Measures

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
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

Full Information

First Posted
October 10, 2022
Last Updated
September 18, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05582434
Brief Title
Experience With Topical Acne Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One gel treatment
Arm Type
Experimental
Arm Description
Every participant will be instructed to apply a topical retinoid every day.
Arm Title
Two gel treatment
Arm Type
Experimental
Arm Description
One-third of the participants will be instructed to apply adapalene and the clindamycin phosphate/benzoyl peroxide gel every day.
Arm Title
Three gel treatment
Arm Type
Experimental
Arm Description
One-third of the participants will be instructed to apply adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.
Intervention Type
Drug
Intervention Name(s)
Adapalene Gel
Other Intervention Name(s)
Differin
Intervention Description
Single topical treatment arm topical to be applied daily to area affected
Intervention Type
Drug
Intervention Name(s)
Adapalene Gel and the clindamycin phosphate/benzoyl peroxide gel
Other Intervention Name(s)
Differin and ONEXTON
Intervention Description
Two topical treatments will be dispensed and instructions to apply daily to affected area
Intervention Type
Drug
Intervention Name(s)
adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.
Other Intervention Name(s)
Differin, Epsolay, Clindamycin
Intervention Description
Three topical treatments will be dispensed and instructions to apply daily to affected area arm.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached
Time Frame
End of study visit - day 56
Title
Medication Adherence
Description
Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened
Time Frame
End of study visit - day 56
Secondary Outcome Measure Information:
Title
Gender specific adherence (female subjects)
Description
Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome
Time Frame
End of study visit - day 56
Title
Gender specific adherence (male subjects)
Description
Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome
Time Frame
End of study visit - day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20618564
Citation
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.
Results Reference
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PubMed Identifier
27784999
Citation
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.
Results Reference
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PubMed Identifier
23572294
Citation
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.
Results Reference
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Experience With Topical Acne Treatment

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