AcnePhase 4NCT00437151
Analysis of Adherence & Associated Factors in Teenagers Undergoing Treatment of Acne Vulgaris With Differin® Gel 0.1%
A Phase 4 study testing More frequent than normal office visits, Electronic reminders (voice, e-mail, text messages) and Parenteral involvement / intervention reminders in people with Acne, run by Galderma R&D at 1 site in United States.
Trial summary
The primary objective of this study is to investigate potential differences in treatment adherence by teenagers among four interventions during treatment for acne. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Acne
- What is being tested?
- More frequent than normal office visits, Electronic reminders (voice, e-mail, text messages) and Parenteral involvement / intervention reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris
Who cannot join
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
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 in treatment adherence by teenagers among four interventions during treatment for acne.
Read the detailed description
Same as above.
- Conditions
- Acne
- Being tested
- More frequent than normal office visits, Electronic reminders (voice, e-mail, text messages), Parenteral involvement / intervention reminders, No intervention or reminders
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
More frequent than normal office visitsOther
Mode of patient reminder
Electronic reminders (voice, e-mail, text messages)Other
Mode of patient reminder
Parenteral involvement / intervention remindersOther
Mode of patient reminder
No intervention or remindersOther
Mode of patient reminder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | More frequent than normal office visits Receives: Other: More frequent than normal office visits |
| 2 | Active comparator | Electronic reminders (voice, e-mail, text messages) Receives: Other: Electronic reminders (voice, e-mail, text messages) |
| 3 | Active comparator | Parental involvement / intervention reminders Receives: Other: Parenteral involvement / intervention reminders |
| 4 | Active comparator | No intervention or reminders Receives: Other: No intervention or reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Percent adherence calculated from MEMS Caps readings
Measured: 12 weeks
Secondary outcomes (2)
Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire
Measured: 12 weeks
Safety - tolerability and adverse event reporting
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 posted19 Feb 2007 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald W Gottschalk, MD, Study director, Galderma Laboratories, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437151
- Sponsor's protocol ID
- US10022
- Status last verified
- Mar 2008
- First submitted
- 16 Feb 2007
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. 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
- NCT00437151
- Acronym / sponsor ID
- US10022
- Conditions
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
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 in treatment adherence by teenagers among four interventions during treatment for acne.
Detailed description
Same as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: More frequent than normal office visitsMore frequent than normal office visits |
| 2 | Active comparator | Other: Electronic reminders (voice, e-mail, text messages)Electronic reminders (voice, e-mail, text messages) |
| 3 | Active comparator | Other: Parenteral involvement / intervention remindersParental involvement / intervention reminders |
| 4 | Active comparator | Other: No intervention or remindersNo intervention or reminders |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent subjects with a diagnosis of moderate to severe Acne vulgaris
Key exclusion criteria (1 listed)
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring more than topical treatment (e.g. oral isotretinoin)
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 |
|---|---|---|
| More frequent than normal office visitsMode of patient reminder | Other | 1 |
| Electronic reminders (voice, e-mail, text messages)Mode of patient reminder | Other | 2 |
| Parenteral involvement / intervention remindersMode of patient reminder | Other | 3 |
| No intervention or remindersMode of patient reminder | Other | 4 |
Primary outcome
Efficacy - Percent adherence calculated from MEMS Caps readings
Time frame: 12 weeks
2 secondary outcomes
Efficacy - lesion counts; percent adherence as calculated by product weights and by Subject's Diary; Global Severity Assessment; Global Assessment of Improvement; Subject questionnaire
Time frame: 12 weeks
Safety - tolerability and adverse event reporting
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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.
Ronald W Gottschalk, MD study director
Galderma Laboratories, LP
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 More frequent than normal office visits, Electronic reminders (voice, e-mail, text messages) and Parenteral involvement / intervention reminders in people with Acne, run by Galderma R&D 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 1 inclusion and 1 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 29 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy - Percent adherence calculated from MEMS Caps readings (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 29 Jul 2022.