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A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607853
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : December 24, 2013
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE May 23, 2012
First Posted Date  ICMJE May 30, 2012
Results First Submitted Date  ICMJE November 4, 2013
Results First Posted Date  ICMJE December 24, 2013
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
Change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) at end of treatement compared to baseline. [ Time Frame: 3 weeks ]
TCS range from 0 (all signs absent) to 9 (all signs severe)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Change in Total Clinical Score at Day 4 Compared to Baseline [ Time Frame: Baseline to day 4 ]
    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.
  • Change in Total Clinical Score at Day 8 Compared to Baseline [ Time Frame: Baseline to day 8 ]
    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.
  • Change in Total Clinical Score at Day 11 Compared to Baseline [ Time Frame: Baseline to day 11 ]
    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.
  • Change in Total Clinical Score at Day 15 Compared to Baseline [ Time Frame: Baseline to day 15 ]
    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.
  • Change in Total Clinical Score at Day 18 Compared to Baseline [ Time Frame: Baseline to day 18 ]
    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.
  • Change From Baseline in Erythema at Day 4. [ Time Frame: Baseline to day 4 ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Erythema at Day 8. [ Time Frame: Baseline to day 8 ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Erythema at Day 11 [ Time Frame: Baseline to day 11 ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Erythema at Day 15 [ Time Frame: Baseline to day 15 ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Erythema at Day 18 [ Time Frame: Baseline to day 18 ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Erythema at Day 22 [ Time Frame: Baseline to day 22 ]
    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Infiltration at Day 4 [ Time Frame: Baseline to day 4 ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Infiltration at Day 8 [ Time Frame: Baseline to day 8 ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Infiltration at Day 11 [ Time Frame: Baseline to day 11 ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Infiltration at Day 15 [ Time Frame: Baseline to day 15 ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Infiltration at Day 18 [ Time Frame: Baseline to day 18 ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Infiltration at Day 22 [ Time Frame: Baseline to day 22 ]
    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Scaling at Day 4 [ Time Frame: Baseline to day 4 ]
    Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Scaling at Day 8 [ Time Frame: Baseline to day 8 ]
    Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Scaling at Day 11 [ Time Frame: Baseline to day 11 ]
    Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Scaling at Day 15 [ Time Frame: Baseline to day 15 ]
    Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Scaling at Day 18 [ Time Frame: Baseline to day 18 ]
    Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • Change From Baseline in Scaling at Day 22 [ Time Frame: Baseline to day 22 ]
    Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Clinical criteria: Change in single clinical sign score and Change in Total Clinical Score (TCS) [ Time Frame: 3 weeks ]
    Clinical criteria:
    • Change in single clinical sign score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline
    • Change in Total Clinical Score (TCS) at individual visits compared to baseline.
  • Ultrasonography [ Time Frame: 3 weeks ]
    Change in lesion thickness (total and echo-poor band) measured by ultrasound at end of treatment compared to baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris
Official Title  ICMJE 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
Brief 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 plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)
    Once daily application, 3 weeks
  • Drug: Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)
    Once daily application, 3 weeks
  • Drug: Daivobet® gel applied for 24 hours (+/- 2 hours)
    Once daily application, 3 weeks
  • Drug: Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)
    Once daily application, 3 weeks
Study Arms  ICMJE Experimental: Daivobet® gel
Interventions:
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Age 18 years or above.
  3. Either sex.
  4. All skin types.
  5. 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.
  6. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (baseline).
  7. 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.
  8. Subjects willing and able to follow all the study procedures and complete the whole study.
  9. Subjects affiliated to a social security system.
  10. 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).
  11. Female with a negative urine pregnancy test (at screening visit).

Exclusion Criteria:

  1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
  2. 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.
  3. 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.
  4. 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).
  5. 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.

  6. 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.
  7. Subjects using emollients on the target plaques within one week before randomisation and during the study.
  8. 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.
  9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
  10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history.
  11. 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.
  12. 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.
  13. 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).
  14. 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).
  15. Subjects with current participation in any other interventional clinical trial, based on interview of the subject.
  16. Subjects with known or suspected hypersensitivity to component(s) of the investigational products.
  17. Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis.
  18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit.
  19. Subjects impossible to contact in case of emergency.
  20. 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).
  21. Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation.
  22. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.
  23. Subjects previously randomised in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607853
Other Study ID Numbers  ICMJE LP0076-57
2012-001507-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine Queille-Roussel, MD Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France
PRS Account LEO Pharma
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP