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

NCT00696449 | Completed Phase 4 Results

• 2 other identifiers: IRB0000040631219
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

Drug: Adapalene; Behavioral: Standard of care

Interventions

Adapalene DRUG

All Subjects will treat the face once daily in the evening.

Also known as: Differin® Gel, 0.1%

Electronic reminder; Frequent visits; Parent reminder; Standard of care

frequent visits BEHAVIORAL

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.

Frequent visits

electronic reminder BEHAVIORAL

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.

Electronic reminder

Parent reminder BEHAVIORAL

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.

Parent reminder

Standard of care BEHAVIORAL

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.

Standard of care

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Standard of Care

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Steven Feldman
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

3367167740

Study Officials

• Steve Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: June 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: October 1, 2009
• Last Updated: September 10, 2018
• Results First Posted: March 30, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)