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A Novel Method to Improve Acne Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01176955
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : October 21, 2011
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

August 5, 2010
August 6, 2010
July 1, 2011
October 21, 2011
January 19, 2018
May 2009
August 2010   (Final data collection date for primary outcome measure)
The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. [ Time Frame: 12 weeks ]
Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.
The measured adherence (measured via the Medication Event Monitoring System, MEMS) of the Internet survey group compared to the no-intervention control group. [ Time Frame: 12 weeks ]
Adherence to the study medication (benzoyl peroxide 5% gel, used by all study subjects) will be measured via MEMS caps, which attach to medication tubes and record when medication tubes are opened and closed. Adherence will be compared between the internet survey group and the control group, who will not complete weekly internet surveys.
Complete list of historical versions of study NCT01176955 on ClinicalTrials.gov Archive Site
  • The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. [ Time Frame: Baseline to 12 weeks ]
    Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.
  • The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. [ Time Frame: Baseline to 12 weeks ]
    Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.
  • The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment. [ Time Frame: 12 weeks ]
    All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.
  • The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study. [ Time Frame: 12 weeks ]
    Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.
  • The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts. [ Time Frame: 12 weeks ]
    Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator.
  • The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey. [ Time Frame: 12 weeks ]
    Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps.
  • The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment. [ Time Frame: 12 weeks ]
    All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.
Not Provided
Not Provided
 
A Novel Method to Improve Acne Outcomes
A Novel Method for Improving Acne Outcomes
This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Behavioral: Internet survey
    A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication.
  • Drug: Benzoyl peroxide 5% gel
    Topical benzoyl peroxide 5% gel, to be used once daily to the face.
  • Experimental: Internet survey
    Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
    Interventions:
    • Behavioral: Internet survey
    • Drug: Benzoyl peroxide 5% gel
  • Placebo Comparator: Control
    Subjects will receive standard-of-care treatment with the study medication, without internet surveys.
    Intervention: Drug: Benzoyl peroxide 5% gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist.
  • written consent of participation must be given by parent or guardian and child.

Exclusion Criteria:

  • Age less than 13 or greater than 18 years of age.
  • Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
  • Inability to complete all study-related visits.
  • Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
  • Subjects may not use topical retinoids or other benzoyl peroxide products, including Proactiv® or topical prescription medications while enrolled in the study.
  • Women that are actively trying to become pregnant or wish to become pregnant during the time frame the study is to take place will be excluded.
  • Subjects will be carefully selected for this study and only those deemed appropriate for treatment with benzoyl peroxide will be placed on this medication.
Sexes Eligible for Study: All
13 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01176955
8982
No
Not Provided
Not Provided
Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
Not Provided
Study Director: Steven R Feldman, MD, PhD Wake Forest University
Wake Forest University Health Sciences
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP