Atopic DermatitisPhase 4NCT00693693
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
A Phase 4 study testing hydrocortisone 17-butyrate 0.1% Cream preparation, hydrocortisone 17-butyrate 0.1% Ointment preparation and hydrocortisone 17-butyrate 0.1% Lipocream preparation in people with Atopic Dermatitis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- hydrocortisone 17-butyrate 0.1% Cream preparation, hydrocortisone 17-butyrate 0.1% Ointment preparation and hydrocortisone 17-butyrate 0.1% Lipocream preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age.
- Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
- Subjects must have >5% TBSA and <30% to be enrolled.
- Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Who cannot join
- Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
- Requiring >130 gm of cream in a 2 week period.
- Having facial or groin involvement of their disease.
- Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
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
The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
Read the detailed description
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.
The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.
Adherence will be measured by MEMs cap.
- Conditions
- Atopic Dermatitis
- Being tested
- hydrocortisone 17-butyrate 0.1% Cream preparation, hydrocortisone 17-butyrate 0.1% Ointment preparation, hydrocortisone 17-butyrate 0.1% Lipocream preparation
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisone 17-butyrate 0.1% Cream preparationDrug
Also called Locoid
Apply medication twice a day to affected areas of atopic dermatitis
hydrocortisone 17-butyrate 0.1% Ointment preparationDrug
Also called locoid
Apply medication twice a day to affected areas of atopic dermatitis
hydrocortisone 17-butyrate 0.1% Lipocream preparationDrug
Also called locoid
Apply medication twice a day to affected areas of atopic dermatitis
| Study group | Role | What they receive |
|---|---|---|
| Cream- | Active comparator | topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis Receives: Drug: hydrocortisone 17-butyrate 0.1% Cream preparation |
| Ointment | Active comparator | topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis Receives: Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation |
| Lipocream | Active comparator | topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis Receives: Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Locoid
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionSep 2008
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 Atopic DermatitisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT00693693
- Sponsor's protocol ID
- IRB00000702
- Status last verified
- Aug 2018
- First submitted
- 5 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
- Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00693693
- Acronym / sponsor ID
- IRB00000702
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Posted 17 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 purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.
Detailed description
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software.
The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions.
Adherence will be measured by MEMs cap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cream- | Active comparator | Drug: hydrocortisone 17-butyrate 0.1% Cream preparationtopical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis |
| Ointment | Active comparator | Drug: hydrocortisone 17-butyrate 0.1% Ointment preparationtopical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis |
| Lipocream | Active comparator | Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparationtopical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age.
- Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale)
- Subjects must have >5% TBSA and <30% to be enrolled.
- Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.
Key exclusion criteria (6 listed)
- Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
- Requiring >130 gm of cream in a 2 week period.
- Having facial or groin involvement of their disease.
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 |
|---|---|---|
| hydrocortisone 17-butyrate 0.1% Cream preparationAlso: LocoidApply medication twice a day to affected areas of atopic dermatitis | Drug | Cream- |
| hydrocortisone 17-butyrate 0.1% Ointment preparationAlso: locoidApply medication twice a day to affected areas of atopic dermatitis | Drug | Ointment |
| hydrocortisone 17-butyrate 0.1% Lipocream preparationAlso: locoidApply medication twice a day to affected areas of atopic dermatitis | Drug | Lipocream |
Primary outcome
Adherence to Locoid
Time frame: 2 weeks
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
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 hydrocortisone 17-butyrate 0.1% Cream preparation, hydrocortisone 17-butyrate 0.1% Ointment preparation and hydrocortisone 17-butyrate 0.1% Lipocream preparation in people with Atopic Dermatitis, 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 4 inclusion and 6 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 17 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 Locoid (time frame: 2 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.