Analysis of Adherence in Subjects Undergoing Differin Gel... | NCT00696449

NCT00696449

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
31219

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Frequent visits	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 Behavioral: frequent visits
Electronic reminder	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 Behavioral: electronic reminder
Parent reminder	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 Behavioral: Parent reminder
Standard of care	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.

Name	Type	Description	Arm Group Labels	Other Names
Adapalene	Drug	All Subjects will treat the face once daily in the evening.	Electronic reminder Frequent visits Parent reminder Standard of care

Measure	Description	Time Frame
Adherence to Treatment	Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap	12 weeks

Eligibility Module

Eligibility 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.

Name	Affiliation	Role
Steve Feldman, MD, PhD	Wake Forest University Health Sciences	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences Dermatology		Winston-Salem	North Carolina	27157	United States

Arm/Group Information

ID	Title	Description
FG000	Frequent Office Visits	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.
FG001	Electronic Reminders	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.
FG002	Parental Reminders	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.
FG003	Standard of Care Control	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Frequent Office Visits	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.
BG001	Electronic Reminders

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adherence to Treatment

Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap

Posted

Median

Full Range

Percent of prescribed doses

12 weeks

ID	Title	Description
OG000	Frequent Office Visits	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.
OG001	Electronic Reminders	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Frequent Office Visits	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.

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic