Atopic DermatitisPhase 4NCT00546000

Cutivate Lotion HPA Axis Pediatric Study

A Phase 4 study testing Fluticasone propionate 0.05% lotion in people with Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis. Read more about this study

Who is it for?: Ages 3 to 12 months
Conditions the study is for: Atopic Dermatitis
What is being tested?: Fluticasone propionate 0.05% lotion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 10 sitesUnited States
Study dates: Jul 2007to Dec 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 3 to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

Subjects are 3-12 months of age
Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
Subjects meet protocol specific AD signs and symptom severity score

Who cannot join

Subjects with conditions effecting the HPA Axis
Subjects with clinically significant systemic disease
Subjects who require treatment with systemic or topical retinoids during the study
Subjects who have been treated with various chronic therapies identified in the protocol
Subjects who have received other investigational drug treatment within 30 days prior to study entry

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Dermatology Center for Children and Young Adults
Eagan, Minnesota, 55121-1176
University of Texas Medical Branch
Galveston, Texas, 77555-0783
University of Texas Health Science Center
Houston, Texas, 77030
University of Miami, Dept. of Dermatology
Miami, Florida, 33125
Adult & Pediatric Dermatology
Overland Park, Kansas, 66211
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, 19103
Centre for Health Care Medical Associates
Poway, California, 92064
Rady Children's Hospital, San Diego
San Diego, California, 92123
Central Dermatology
St Louis, Missouri, 63117
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

Conditions: Atopic Dermatitis
Being tested: Fluticasone propionate 0.05% lotion
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluticasone propionate 0.05% lotionDrug
Daily applications

Study groups in NCT00546000
Study group	Role	What they receive
1	Experimental	Receive between 22 and 29 days of Cutivate lotion treatment Receives: Drug: Fluticasone propionate 0.05% lotion

What is being measured

The primary outcome is the main question the study is designed to answer.

Post Treatment Serum Cortisol Values Will be Compared.
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.
Measured: Up to 29 days of treatment

Secondary outcomes (1)

Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.
Measured: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Dec 2008

First posted18 Oct 2007 (estimated)
Study startJul 2007
Primary completionDec 2008
Study completionDec 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00546000
Sponsor's protocol ID: ALT 0434-01-01
Status last verified: Jun 2014
First submitted: 16 Oct 2007
Last updated: 24 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population
ClinicalTrials.gov ID: NCT00546000
Acronym / sponsor ID: ALT 0434-01-01
Conditions: Atopic Dermatitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 18 Oct 2007 (estimated)
Results: Posted 24 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Fluticasone propionate 0.05% lotionReceive between 22 and 29 days of Cutivate lotion treatment

Who may qualify

Ages: 3 to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Subjects are 3-12 months of age
Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
Subjects meet protocol specific AD signs and symptom severity score

Key exclusion criteria (5 listed)

Subjects with conditions effecting the HPA Axis
Subjects with clinically significant systemic disease
Subjects who require treatment with systemic or topical retinoids during the study
Subjects who have been treated with various chronic therapies identified in the protocol
Subjects who have received other investigational drug treatment within 30 days prior to study entry

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
Fluticasone propionate 0.05% lotionDaily applications	Drug	1

Primary outcome

Post Treatment Serum Cortisol Values Will be Compared.
Time frame: Up to 29 days of treatment
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.

1 secondary outcome

Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
Time frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29

Results and safety

Results posted to the registry on 24 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	56	52

Primary outcome: Post Treatment Serum Cortisol Values Will be Compared.

Time frame: Up to 29 days of treatment. Number. Unit: participants

Measure	Experimental n = 56
Value	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 29 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	1 of 56 (1.8%)	25 of 56 (44.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atopic Dermatitis

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

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.

Alan Fleischer Jr., M.D. principal investigator

Wake Forest University Health Sciences

Lawrence F. Eichenfield, MD principal investigator

Rady Children's Hospital, San Diego

Elizabeth Connelly, MD principal investigator

University of Miami

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone propionate 0.05% lotion in people with Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. at 10 sites 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 3 inclusion and 5 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 24 Jul 2014). 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?

Post Treatment Serum Cortisol Values Will be Compared. (time frame: Up to 29 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546000.

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 24 Jul 2014.