Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene; frequent visits; electronic reminder; Parent reminder; Standard of care
Intervention description: All 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.; 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.; 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.; 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.
Intervention MeSH terms: Adapalene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to investigate potential differences between four
      treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%.
      Differin is approved by the Food and Drug Administration (FDA) to treat acne.
    

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.