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Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%

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ClinicalTrials.gov Identifier: NCT00437151
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Galderma Laboratories, L.P.

Brief Summary:
The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

Condition or disease Intervention/treatment Phase
Acne Other: More frequent than normal office visits Other: Electronic reminders (voice, e-mail, text messages) Other: Parenteral involvement / intervention reminders Other: No intervention or reminders Phase 4

Detailed Description:
Same as above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin® Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris.
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
More frequent than normal office visits
Other: More frequent than normal office visits
Mode of patient reminder
Active Comparator: 2
Electronic reminders (voice, e-mail, text messages)
Other: Electronic reminders (voice, e-mail, text messages)
Mode of patient reminder
Active Comparator: 3
Parental involvement / intervention reminders
Other: Parenteral involvement / intervention reminders
Mode of patient reminder
Active Comparator: 4
No intervention or reminders
Other: No intervention or reminders
Mode of patient reminder



Primary Outcome Measures :
  1. Efficacy - Percent adherence calculated from MEMS Caps readings [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire [ Time Frame: 12 weeks ]
  2. Safety - tolerability and adverse event reporting [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris

Exclusion Criteria:

  • Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437151


Locations
United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, LP

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00437151     History of Changes
Other Study ID Numbers: US10022
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents