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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437151
First Posted: February 19, 2007
Last Update Posted: March 31, 2008
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.
Information provided by:
Galderma Laboratories, L.P.
  Purpose
The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne.

Condition Intervention 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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

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

Secondary Outcome Measures:
  • 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 ]
  • Safety - tolerability and adverse event reporting [ Time Frame: 12 weeks ]

Enrollment: 61
Study Start Date: June 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Same as above.
  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

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 Submitted: February 16, 2007
First Posted: February 19, 2007
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