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

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00437151

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 IV

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:

MedlinePlus related topics: Acne

Drug Information available for: Adapalene

U.S. FDA Resources

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 February 09, 2012