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

This study has been completed.
Sponsor:
Information provided by:
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00437151
First received: February 16, 2007
Last updated: March 27, 2008
Last verified: March 2008
  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 Blind (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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Safety - tolerability and adverse event reporting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00437151     History of Changes
Other Study ID Numbers: US10022
Study First Received: February 16, 2007
Last Updated: March 27, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 23, 2014