A study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
- Conditions
- itchy psoriasisMedDRA version: 14.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-000253-30-DE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1.Signed informed consent has been obtained
2.Age 18 years or above
3.Either sex
4.Any race or ethnicity
5.Attending hospital outpatient clinic or the private practice of a dermatologist
6.Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric distribution
7.Two treatment areas with a symmetrical distribution each corresponding to 2-3% BSA and each including at least one itchy psoriasis plaque
8.Itchy psoriasis on both intended treatment areas of at least 40mm on the Visual Analogue Scale (VAS) with a maximum difference of 10mm on the visual ana-logue scale between each of the two treatment areas
9.Disease severity graded mild, moderate or severe according to the Physician’s global assessment (PGA) of disease severity on psoriasis plaques on each of the two treatment areas. The disease severity must be the same for both treatment areas
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 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 2
1.Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
• etanercept – within 4 weeks prior to randomisa-tion
• adalimumab, infliximab – within 8 weeks prior to randomisation
• ustekinumab – within 16 weeks prior to randomisation
• other products – 4 weeks/5 half-lives (whichev-er is longer)
2.Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticoster-oids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
3.Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
4.Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
• antihistamins – within 1 week prior to randomi-sation
• gabapentin – within 4 weeks prior to randomi-sation
5.Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following regis-tration) within the 4-week period prior to randomisa-tion or longer, if the class of substance required a longer treatment free period as defined in exclusion criterion 1 for biological treatments
6.PUVA or Grenz ray therapy within 4 weeks prior to randomisation.
7.UVB therapy within 2 weeks prior to randomisation
8.Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
9.Subjects with current participation in any other interventional clinical trial
10.Subjects with any of the following conditions present on the treatment areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infec-tions, parasitic infections, skin manifestations in rela-tion to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ic-thyosis, ulcers and wounds
11.Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis
12.Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investiga-tional products or formulations being tested
13.Known or suspected severe renal insufficiency or severe hepatic disorders
14.Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
15.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 should be avoid-ed)
16.Subjects previously randomised into this trial
17.Subjects known or, in the opinion of the investigator, being unlikely to comply with the Clinical Study Pro-tocol (e.g., due to alcoholism, drug dependency or psychotic state)
18.Females who are pregnant, females of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
19.Females of child-bearing potential with positive pregnancy test at visit 1
20.Subjects (or their partner) not using an adequate method of contraception (according to national re-quirements, as applicable)
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Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the clinical efficacy on itch of treatment with cromoglicate cream in subjects with itchy psoriasis;Secondary Objective: To investigate the safety of treatment with cromoglicate cream in subjects with itchy psoriasis<br><br>To investigate pharmacodynamic parameters related to itch and the mode of action of cromoglicate<br>;Primary end point(s): Change in Visual analog scale of itch from baseline to end of treatment;Timepoint(s) of evaluation of this end point: day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in 4-point itch scale from baseline to end of treatment<br>Change in 7-point itch scale from baseline to end of treatment<br>;Timepoint(s) of evaluation of this end point: day 14