EO 90110 ointment in the treatment of psoriasis vulgaris

Active, not recruiting

• Conditions: psoriasis vulgaris; MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2010-021941-38-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Following verbal and written information about the trial, the subject has provided signed and dated in-formed consent before any study related activity is carried out, including activities relating to the wash-out period
2.Clinical diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk amenable for topical treatment
3.Two symmetrically distributed lesions, one on each side of the body, located on arms, legs or trunk, fulfilling the following criteria:
a. Size
Each lesion of minimum 0.5% and maximum 1% of total body surface area. The two lesions should be of similar size according to the Investigator’s judge-ment.
b. Total Clinical Score
Each lesion with a Total Clinical Score of at least 5. Any difference in Total Clinical Score between the two lesions should be of maximum ‘1’.
c. Severity
Severity of each lesion at least mild according to Investigator’s Global Assessment. Severity score must be the same for both lesions.
4.Aged 18 years or above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Systemic treatment with biological therapies
directed against or with a potential effect on psoriasis
vulgaris, within the following time period:
- etanercept: within 4 weeks prior to randomisation
- adalimumab, infliximab: within 2 months prior to
randomisation
- alefacept, ustekinumab: within 4 months prior to
randomisation
2. Systemic treatment with all other than biological
therapies with a potential effect on psoriasis vulgaris
(e.g. corticosteroids, retinoids, immunosuppressants,
salazopyrin) within 4 weeks prior to randomisation
3. PUVA therapy or Grenz ray therapy within 4
weeks prior to randomisation
4. UVB therapy within 2 weeks prior to randomisation
5. Topical treatment with potent or very potent WHO
group III and IV corticosteroids within 2 weeks
prior to randomisation
6. Any topical treatment (except for emollients) of
the two selected target lesions within 2 weeks prior
to randomisation
7. Planned initiation of, or planned changes to,
concomitant medication that may affect psoriasis
vulgaris (e.g., beta blockers, chloroquine, lithium
and ACE inhibitors) within 2 weeks prior to randomisation
and during the study
8. Treatment with drugs sensitive to CYP3A4 or
CYP2D6 metabolism within 5 half lives prior to randomisation
9. Current diagnosis of guttate, erythrodermic,
exfoliative or pustular psoriasis
10. Any of the following conditions present on the two
selected target lesions: Infectious skin disorder,
eczematous skin, atopic dermatitis, ulcers or wounds
11. Skin disease on the two selected target lesions that
may confound the evaluation of psoriasis vulgaris
(e.g., seborrhoiec dermatitis, contact dermatitis or
fungal infection) as judged by the Investigator
12. Planned exposure to the sun during the study that
may affect psoriasis vulgaris (i.e., normal lifestyle
outdoor activities are permitted but deliberate exposure
to sunlight or artificial ultraviolet light to the
two selected target lesions should be avoided)
13. Clinically significant cardiac, endocrinologic,
pulmonary, neurologic, psychiatric, hepatic, renal,
haematologic, malignant or gastrointestinal disease,
immunologic insufficiency, or other major diseases
or current condition which, in the opinion of the
Investigator, would put the subject at risk by participating
in the study or would interfere with the
evaluation of study results
14. History of immune deficiency condition (e.g.,
lymphoma, HIV or Wiskott-Aldrich Syndrome)
15. Chronic or ongoing infectious disease requiring
systemic treatment such as, but not limited to,
chronic renal infection, chronic chest infection with
bronchiectasis, tuberculosis, active hepatitis B, active
hepatitis C, HIV positive
16. Known or suspected hypersensitivity to component(
s) of the investigational products
17. Current participation in any other interventional
clinical trial
18. 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 last
4 weeks prior to randomisation, or for biologics,
within the last 12 weeks prior to randomisation
19. Previously randomised in this trial
20. Known or suspected to be unlikely to comply with
the Clinical Study Protocol (e.g., due to alcoholism,
drug dependency or psychotic state)
21. Female subjects who are pregnant, of child-bearing
potential and wishing to become pregnant during the
trial, or are breast feeding
22. Female subjects of childbearing potential1 expected
not using an adequate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified