Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
This study has been completed.
Sponsor:
Galderma Laboratories, L.P.
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
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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 May 22, 2013