PsoriasisPhase 4NCT01137032
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
A Phase 4 study testing Pandel Cream 0.1% in people with Psoriasis and Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- Pandel Cream 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2004to Aug 2005
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
- Good health with the exception of psoriasis or atopic dermatitis
Who cannot join
- Any disease affecting the HPA-axis
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Oswald Mikell, MD
Hilton Head Island, South Carolina, 29926
Michael Gold, MD
Nashville, Tennessee, 37215
Christopher Huerter, MD
Omaha, Nebraska, 68130
About this study
Official title: An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- Pandel Cream 0.1%
- Keywords
- Psoriasis, Atopic Dermatitis
- Medical subject headings
- Psoriasis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandel Cream 0.1%Drug
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Pandel Cream 0.1% | Experimental | Pandel Cream 0.1% Receives: Drug: Pandel Cream 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-injection Serum Cortisol Level
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
Measured: 22 Days
Secondary outcomes (2)
Pre-injection Serum Cortisol Levels
The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.
Measured: 22 Days
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2004
- Primary completionAug 2005
- Study completionAug 2005
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 PsoriasisStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fougera Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela C Kaplan, Study director, Fougera Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137032
- Sponsor's protocol ID
- ALT 0153-01-1
- Status last verified
- Mar 2016
- First submitted
- 2 Jun 2010
- Last updated
- 4 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population
- ClinicalTrials.gov ID
- NCT01137032
- Acronym / sponsor ID
- ALT 0153-01-1
- Conditions
- Psoriasis, Atopic Dermatitis
- Keywords
- Psoriasis, Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 29 Mar 2016
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 study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pandel Cream 0.1% | Experimental | Drug: Pandel Cream 0.1%Pandel Cream 0.1% |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
- Good health with the exception of psoriasis or atopic dermatitis
Key exclusion criteria (2 listed)
- Any disease affecting the HPA-axis
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
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 |
|---|---|---|
| Pandel Cream 0.1%A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days | Drug | Pandel Cream 0.1% |
Primary outcome
Post-injection Serum Cortisol Level
Time frame: 22 Days
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
2 secondary outcomes
Pre-injection Serum Cortisol Levels
Time frame: 22 Days
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
Time frame: 22 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Angela C Kaplan study director
Fougera Pharmaceuticals Inc.
3 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 Pandel Cream 0.1% in people with Psoriasis and Atopic Dermatitis, run by Fougera Pharmaceuticals Inc. at 3 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 2 inclusion and 2 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 29 Mar 2016). 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-injection Serum Cortisol Level (time frame: 22 Days). 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 4 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.