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

• Sponsor: Wake Forest University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00696449
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 4
• Duration (Months): 40
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene; Behavioral: frequent visits; Behavioral: electronic reminder; Behavioral: Parent reminder; Behavioral: Standard of care	Phase 4

Detailed Description

Subjects will be enrolled and randomized in a 1:1:1:1 ratio to one of four treatment intervention groups. All Subjects will be treated once-daily for 12 weeks with Differin® Gel, 0.1%. The four intervention groups were designated according to follow-up strategies as follows:

• More frequent than normal office visits

• Electronic reminders (voice, e-mail, text messages)

• Parental involvement/intervention reminders

• No intervention or reminders

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• 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
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Frequent 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.	Drug: Adapalene; All Subjects will treat the face once daily in the evening.; Other Names: Differin® Gel, 0.1% ; Behavioral: frequent 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.
Experimental: Electronic reminder 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; All Subjects will treat the face once daily in the evening.; Other Names: Differin® Gel, 0.1% ; Behavioral: electronic reminder; 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.
Experimental: Parent reminder 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; All Subjects will treat the face once daily in the evening.; Other Names: Differin® Gel, 0.1% ; Behavioral: Parent reminder; 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.
Experimental: Standard of care 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; All Subjects will treat the face once daily in the evening.; Other Names: Differin® Gel, 0.1% ; Behavioral: Standard of care; 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.

Outcome Measures

Primary Outcome Measures

1. Adherence to Treatment [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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 Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT00696449
• Other Study ID Numbers: IRB00000406; 31219
• First Posted: Jun 12, 2008
• Last Update Posted: Sep 10, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris; Adapalene

Study Results

Participant Flow

Arm/Group Title	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control
Arm/Group Description	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.
Period Title: Overall Study
STARTED	15	15	15	16
COMPLETED	12	9	14	13
NOT COMPLETED	3	6	1	3

Baseline Characteristics

Arm/Group Title	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	15	15	15	16	61
Age (Count of Participants)
<=18 years	15 100%	15 100%	15 100%	16 100%	61 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 46.7%	8 53.3%	9 60%	10 62.5%	34 55.7%
Male	8 53.3%	7 46.7%	6 40%	6 37.5%	27 44.3%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	15 100%	16 100%	61 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Frequent Office Visits	Electronic Reminders	Parental Reminders	Standard of Care Control
Arm/Group Description	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.
Measure Participants	15	15	15	16
Median (Full Range) [Percent of prescribed doses]	64	38	28	52

Adverse Events

Arm/Group Title	Frequent Office Visits		Electronic Reminders		Parental Reminders		Standard of Care Control
Arm/Group Description	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.
All Cause Mortality
	Frequent Office Visits		Electronic Reminders		Parental Reminders		Standard of Care Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Frequent Office Visits		Electronic Reminders		Parental Reminders		Standard of Care Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Frequent Office Visits		Electronic Reminders		Parental Reminders		Standard of Care Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.