Psoriasis VulgarisPhase 2NCT01607853
A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris
A Phase 2 study testing Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) and Daivobet® gel applied for 24 hours (+/- 2 hours) in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) and Daivobet® gel applied for 24 hours (+/- 2 hours)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Oct 2012
- Phase
- Phase 2
- 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
- Following verbal and written information about the trial, the subject has to provide signed and dated informed consent before any study related activities are carried out.
- Age 18 years or above.
- Either sex.
- All skin types.
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 4 different products.
- Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (baseline).
Show all 11Show fewer
- Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive, but each individual item ≥ 1.
- Subjects willing and able to follow all the study procedures and complete the whole study.
- Subjects affiliated to a social security system.
- Female subjects of childbearing potential using a reliable method of contraception for at least 1 month before the study start and during the course of the study (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation).
- Female with a negative urine pregnancy test (at screening visit).
Who cannot join
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
- Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study.
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study.
- Use of phototherapy within the following time periods prior to randomisation and during the study:
- PUVA or Grenz ray therapy (4 weeks),
- UVB (2 weeks).
Show all 33Show fewer
- Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
- Potent or very potent (WHO group III-IV) corticosteroids.
- Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study:
- WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis),
- Topical retinoids,
- Vitamin D analogues,
- Topical immunomodulators (e.g. calcineurin inhibitors),
- Anthracen derivatives,
- Tar,
- Salicylic acid.
- Subjects using emollients on the target plaques within one week before randomisation and during the study.
- Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study.
- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history.
- Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin.
- Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds within the plaque test areas.
- History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency).
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments).
- Subjects with current participation in any other interventional clinical trial, based on interview of the subject.
- Subjects with known or suspected hypersensitivity to component(s) of the investigational products.
- Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis.
- Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit.
- Subjects impossible to contact in case of emergency.
- Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
- Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation.
- Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.
- Subjects previously randomised in this trial.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, 06202
About this study
Official title: A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hours
The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes), Daivobet® gel applied for 24 hours (+/- 2 hours), Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)Drug
Once daily application, 3 weeks
Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)Drug
Once daily application, 3 weeks
Daivobet® gel applied for 24 hours (+/- 2 hours)Drug
Once daily application, 3 weeks
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)Drug
Once daily application, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Daivobet® gel | Experimental | Not described Receives: Drug: Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes); Drug: Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes); Drug: Daivobet® gel applied for 24 hours (+/- 2 hours); Drug: Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Clinical Score From Baseline to Day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score
Measured: baseline to day 22
Secondary outcomes (25)
Change in Total Clinical Score at Day 4 Compared to Baseline
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Measured: Baseline to day 4
Change in Total Clinical Score at Day 8 Compared to Baseline
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Measured: Baseline to day 8
Change in Total Clinical Score at Day 11 Compared to Baseline
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Measured: Baseline to day 11
Change in Total Clinical Score at Day 15 Compared to Baseline
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.
Measured: Baseline to day 15
Change in Total Clinical Score at Day 18 Compared to Baseline
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Measured: Baseline to day 18
Change From Baseline in Erythema at Day 4.
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 4
Change From Baseline in Erythema at Day 8.
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 8
Change From Baseline in Erythema at Day 11
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 11
Change From Baseline in Erythema at Day 15
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 15
Change From Baseline in Erythema at Day 18
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 18
Change From Baseline in Erythema at Day 22
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 22
Change From Baseline in Infiltration at Day 4
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 4
Change From Baseline in Infiltration at Day 8
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 8
Change From Baseline in Infiltration at Day 11
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 11
Change From Baseline in Infiltration at Day 15
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 15
Change From Baseline in Infiltration at Day 18
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 18
Change From Baseline in Infiltration at Day 22
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 22
Change From Baseline in Scaling at Day 4
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 4
Change From Baseline in Scaling at Day 8
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 8
Change From Baseline in Scaling at Day 11
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 11
Change From Baseline in Scaling at Day 15
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 15
Change From Baseline in Scaling at Day 18
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 18
Change From Baseline in Scaling at Day 22
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Measured: Baseline to day 22
Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.
Measured: Baseline to day 22
Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22
Measured: Baseline to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
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 Psoriasis VulgarisStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Queille-Roussel, MD, Principal investigator, Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607853
- Sponsor's protocol ID
- LP0076-57
- Other IDs
- 2012-001507-21
- Status last verified
- Mar 2015
- First submitted
- 23 May 2012
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hours
- ClinicalTrials.gov ID
- NCT01607853
- Acronym / sponsor ID
- LP0076-57
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Posted 24 Dec 2013
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 evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daivobet® gel | Experimental | Drug: Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Drug: Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes), Drug: Daivobet® gel applied for 24 hours (+/- 2 hours), Drug: Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Following verbal and written information about the trial, the subject has to provide signed and dated informed consent before any study related activities are carried out.
- Age 18 years or above.
- Either sex.
- All skin types.
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 4 different products.
Key exclusion criteria (33 listed)
- Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
- Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study.
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study.
- Use of phototherapy within the following time periods prior to randomisation and during the study:
- Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
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 |
|---|---|---|
| Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)Once daily application, 3 weeks | Drug | Daivobet® gel |
| Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)Once daily application, 3 weeks | Drug | Daivobet® gel |
| Daivobet® gel applied for 24 hours (+/- 2 hours)Once daily application, 3 weeks | Drug | Daivobet® gel |
| Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)Once daily application, 3 weeks | Drug | Daivobet® gel |
Primary outcome
Change in Total Clinical Score From Baseline to Day 22
Time frame: baseline to day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score
25 secondary outcomes
Change in Total Clinical Score at Day 4 Compared to Baseline
Time frame: Baseline to day 4
Change in Total Clinical Score at Day 8 Compared to Baseline
Time frame: Baseline to day 8
Change in Total Clinical Score at Day 11 Compared to Baseline
Time frame: Baseline to day 11
Change in Total Clinical Score at Day 15 Compared to Baseline
Time frame: Baseline to day 15
Change in Total Clinical Score at Day 18 Compared to Baseline
Time frame: Baseline to day 18
Change From Baseline in Erythema at Day 4.
Time frame: Baseline to day 4
Change From Baseline in Erythema at Day 8.
Time frame: Baseline to day 8
Change From Baseline in Erythema at Day 11
Time frame: Baseline to day 11
Change From Baseline in Erythema at Day 15
Time frame: Baseline to day 15
Change From Baseline in Erythema at Day 18
Time frame: Baseline to day 18
Change From Baseline in Erythema at Day 22
Time frame: Baseline to day 22
Change From Baseline in Infiltration at Day 4
Time frame: Baseline to day 4
Change From Baseline in Infiltration at Day 8
Time frame: Baseline to day 8
Change From Baseline in Infiltration at Day 11
Time frame: Baseline to day 11
Change From Baseline in Infiltration at Day 15
Time frame: Baseline to day 15
Change From Baseline in Infiltration at Day 18
Time frame: Baseline to day 18
Change From Baseline in Infiltration at Day 22
Time frame: Baseline to day 22
Change From Baseline in Scaling at Day 4
Time frame: Baseline to day 4
Change From Baseline in Scaling at Day 8
Time frame: Baseline to day 8
Change From Baseline in Scaling at Day 11
Time frame: Baseline to day 11
Change From Baseline in Scaling at Day 15
Time frame: Baseline to day 15
Change From Baseline in Scaling at Day 18
Time frame: Baseline to day 18
Change From Baseline in Scaling at Day 22
Time frame: Baseline to day 22
Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.
Time frame: Baseline to day 22
Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22
Time frame: Baseline to day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Psoriasis Vulgaris
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris
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.
Catherine Queille-Roussel, MD principal investigator
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) and Daivobet® gel applied for 24 hours (+/- 2 hours) in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in France.
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 11 inclusion and 33 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 Mar 2025. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dec 2013). 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?
Change in Total Clinical Score From Baseline to Day 22 (time frame: baseline to day 22). 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 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.