Dermatitis, ContactPhase 4WA+TR_1NCT00779792
Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation
A Phase 4 study testing clobetasol, triamcinolone acetonide and tacrolimus in people with Dermatitis, Contact and Dermatitis, Occupational, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Contact, Dermatitis, Occupational
- What is being tested?
- clobetasol, triamcinolone acetonide and tacrolimus
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to Nov 2008
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- caucasian
- normal skin on both volar forearms
- oral and written informed consent
Who cannot join
- pregnant, lactating women
- no safe anticonceptive method used
- intake of systemic immunosuppressants (e.g. prednisolone)
- endocrine, immune, or liver disorders
- known allergy towards drugs applied to the skin
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology, Odense University Hospital
Odense, 5000
About this study
Official title: Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation
The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.
Read the detailed description
Irritant contact dermatitis (ICD) is a frequent cause of hand eczema and occupational skin disease. One way to study ICD is to expose healthy volunteer skin to chemicals and evaluate the skin response. Because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. In this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. Treatment of ICD has classically involved topical steroids and/or emollients. However, the outcome is variable with some patients being very refractory to this regimen. This study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% Glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.
- Conditions
- Dermatitis, Contact, Dermatitis, Occupational
- Being tested
- clobetasol, triamcinolone acetonide, tacrolimus, glycerol, vehicle ointment (paraffin oil/soft white paraffin)
- Keywords
- Irritant contact dermatitis, experimental contact dermatitis, treatment, efficacy, topical steroids, topical immune modulators, glycerol
- Medical subject headings
- Dermatitis, Contact, Dermatitis, Occupational, Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clobetasolDrug
Also called Dermovate
0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days
triamcinolone acetonideDrug
Also called Kenalog
0.5 mg ointment twice daily for 10 consecutive days
tacrolimusDrug
Also called Protopic
0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days
glycerolDrug
0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days
vehicle ointment (paraffin oil/soft white paraffin)Drug
0.5 mg vehicle ointment twice daily for 10 consecutive days
What is being measured
The primary outcome is the main question the study is designed to answer.
level of skin irritation as determined by visual reading, skin redness (color measurement), skin barrier integrity (transepidermal water loss measurement) and skin hydration (capacitance measurement)
Measured: End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, ContactStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma, University of Southern Denmark
- Investigators
- Anders Clemmensen, MD, Principal investigator, Department of Dermatology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779792
- Sponsor's protocol ID
- 2008-001678-34
- Other IDs
- 2008
- Acronym
- WA+TR_1
- Status last verified
- Aug 2008
- First submitted
- 23 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen F, Hedegaard K, Petersen TK, Bindslev-Jensen C, Fullerton A, Andersen KE. Comparison of the effect of glycerol and triamcinolone acetonide on cumulative skin irritation in a randomized trial. J Am Acad Dermatol. 2007 Feb;56(2):228-35. doi: 10.1016/j.jaad.2006.08.063. Epub 2006 Dec 6.
PubMed 17156893Schliemann S, Kelterer D, Bauer A, John SM, Skudlik C, Schindera I, Wehrmann W, Elsner P. Tacrolimus ointment in the treatment of occupationally induced chronic hand dermatitis. Contact Dermatitis. 2008 May;58(5):299-306. doi: 10.1111/j.1600-0536.2007.01314.x.
PubMed 18416762
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation
- ClinicalTrials.gov ID
- NCT00779792
- Acronym / sponsor ID
- WA+TR_1 / 2008-001678-34
- Conditions
- Dermatitis, Contact, Dermatitis, Occupational
- Keywords
- Irritant contact dermatitis, experimental contact dermatitis, treatment, efficacy, topical steroids, topical immune modulators, glycerol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- LEO Pharma, University of Southern Denmark
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 24 Oct 2008 (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 purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.
Detailed description
Irritant contact dermatitis (ICD) is a frequent cause of hand eczema and occupational skin disease. One way to study ICD is to expose healthy volunteer skin to chemicals and evaluate the skin response. Because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. In this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. Treatment of ICD has classically involved topical steroids and/or emollients. However, the outcome is variable with some patients being very refractory to this regimen. This study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% Glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- caucasian
- normal skin on both volar forearms
- oral and written informed consent
Key exclusion criteria (5 listed)
- pregnant, lactating women
- no safe anticonceptive method used
- intake of systemic immunosuppressants (e.g. prednisolone)
- endocrine, immune, or liver disorders
- known allergy towards drugs applied to the skin
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 |
|---|---|---|
| clobetasolAlso: Dermovate0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days | Drug | – |
| triamcinolone acetonideAlso: Kenalog0.5 mg ointment twice daily for 10 consecutive days | Drug | – |
| tacrolimusAlso: Protopic0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days | Drug | – |
| glycerol0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days | Drug | – |
| vehicle ointment (paraffin oil/soft white paraffin)0.5 mg vehicle ointment twice daily for 10 consecutive days | Drug | – |
Primary outcome
level of skin irritation as determined by visual reading, skin redness (color measurement), skin barrier integrity (transepidermal water loss measurement) and skin hydration (capacitance measurement)
Time frame: End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
- Background: PubMed 17156893Andersen F, Hedegaard K, Petersen TK, Bindslev-Jensen C, Fullerton A, Andersen KE. Comparison of the effect of glycerol and triamcinolone acetonide on cumulative skin irritation in a randomized trial. J Am Acad Dermatol. 2007 Feb;56(2):228-35. doi: 10.1016/j.jaad.2006.08.063. Epub 2006 Dec 6.
- Background: PubMed 18416762Schliemann S, Kelterer D, Bauer A, John SM, Skudlik C, Schindera I, Wehrmann W, Elsner P. Tacrolimus ointment in the treatment of occupationally induced chronic hand dermatitis. Contact Dermatitis. 2008 May;58(5):299-306. doi: 10.1111/j.1600-0536.2007.01314.x.
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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.
Anders Clemmensen, MD principal investigator
Department of Dermatology, Odense University Hospital
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 clobetasol, triamcinolone acetonide and tacrolimus in people with Dermatitis, Contact and Dermatitis, Occupational, run by Odense University Hospital at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 24 Oct 2008. 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 Denmark. 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?
Results are not available in the source record.
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?
level of skin irritation as determined by visual reading, skin redness (color measurement), skin barrier integrity (transepidermal water loss measurement) and skin hydration (capacitance measurement) (time frame: End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days). 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 NCT00779792, which also lists 2 linked publications.
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 Oct 2008.