Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris - Full Text View

Sponsor:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00696449

Purpose

The purpose of this research study is to see how well the drug works for subjects who have acne. Adapalene 0.1% (Differin) will be used in this study to treat your acne. Differin is approved by the Food and Drug Administration (FDA) to treat acne.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Adapalene	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Efficacy Study
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 Wake Forest University:

Primary Outcome Measures:

Percent change from baseline in total lesions counts [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global Assessment of improvement from baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2006
Estimated Study Completion Date:	October 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.	Drug: Adapalene Subjects will treat the face once daily in the evening. This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
2: Experimental This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.	Drug: Adapalene Subjects will treat the face once daily in the evening This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
3: Experimental In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.	Drug: Adapalene Subjects will treat the face once daily in the evening n this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
4: Experimental This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.	Drug: Adapalene Subjects will treat the face once daily in the evening This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female Subjects of any race, aged 13 to 18 years inclusive,
Subjects with a diagnosis of moderate to severe Acne vulgaris, measured by lesion counts of a minimum of 15 and a maximum of 50 inflammatory lesions (papules and pustules) on the face, AND a minimum of 30 and a maximum of 125 total lesions. Subjects with nodules may participate in the study.
Female Subjects of childbearing potential must have a negative urine pregnancy test (UPT).
Female Subjects of childbearing potential must practice a highly effective method of contraception during the study
Subjects (and parent/guardian if Subject is under 18 years of age) must be willing and capable of following study instructions to the extent and degree required by the protocol;
Subjects able to follow study instructions and likely to complete all required visits;
Subjects/Representative signs the Informed Consent prior to any study procedures. Subjects under the age of 18 must have one parent or guardian read and sign the Informed Assent Form prior to receiving study treatment but the parent(s) or guardian is not required to attend the follow-up visits unless requested;
Subject must be willing to be photographed and sign a release form allowing photographs to be used.

Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject's participation in the study,
Subjects with known allergy to one of the components of the test products,
Subjects who have participated in another investigational drug or device research study within 30 days of enrolment, Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or or severe acne requiring more than topical treatment (e.g. oral isotretinoin);
Subjects with a beard or other facial hair that might interfere with study assessments;
Subjects with underlying diseases or other dermatological conditions that require the use of interfering topical or systemic therapy such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea;
Subjects who are at risk in terms of precautions, warnings, and contra-indication (see package insert for Differin Gel, 0.1%);
Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.);
Subjects with a known history of drug and/or alcohol abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696449

Locations

United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Steve Feldman, MD, PhD

Wake Forest University

More Information

No publications provided

Responsible Party:	Wake Forest University Health Sciences ( Steve Feldman, MD PhD )
Study ID Numbers:	00000406, 31219
Study First Received:	June 9, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00696449 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Acneiform Eruptions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 09, 2009