Acne VulgarisPhase 4NCT00696449
Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris
A Phase 4 study testing Adapalene, frequent visits and electronic reminder in people with Acne Vulgaris, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene, frequent visits and electronic reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris
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.
Read the 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
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene, frequent visits, electronic reminder, Parent reminder, Standard of care
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdapaleneDrug
Also called Differin® Gel, 0.1%
All Subjects will treat the face once daily in the evening.
frequent visitsBehavioural
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.
electronic reminderBehavioural
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.
Parent reminderBehavioural
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.
Standard of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Adapalene; Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Treatment
Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696449
- Sponsor's protocol ID
- IRB00000406
- Other IDs
- 31219
- Status last verified
- Aug 2018
- First submitted
- 9 Jun 2008
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Adherence and Associated Factors in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00696449
- Acronym / sponsor ID
- IRB00000406
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Frequent visits | Experimental | Drug: Adapalene, Behavioral: frequent visitsThis 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. |
| Electronic reminder | Experimental | Drug: Adapalene, Behavioral: electronic reminderThis 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. |
| Parent reminder | Experimental | Drug: Adapalene, Behavioral: Parent reminderIn 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. |
| Standard of care | Experimental | Drug: Adapalene, Behavioral: Standard of careThis 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdapaleneAlso: Differin® Gel, 0.1%All Subjects will treat the face once daily in the evening. | Drug | Electronic reminder, Frequent visits, Parent reminder, Standard of care |
| frequent visitsThis 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. | Behavioural | Frequent visits |
| electronic reminderThis 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. | Behavioural | Electronic reminder |
| Parent reminderIn 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. | Behavioural | Parent reminder |
| Standard of careThis 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. | Behavioural | Standard of care |
Primary outcome
Adherence to Treatment
Time frame: 12 weeks
Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adapalene, frequent visits and electronic reminder in people with Acne Vulgaris, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.