Cromoglicate in Psoriasis

NCT01722812 | Completed Phase 2

• 1 other identifier: LP0075-34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Evaluation of change in visual analogue scale

  Baseline to week 2

Secondary Outcomes (1)

• Evaluation of change in 4-point itch scale, 7-point itch scale, duration of itch and comparison of treated areas

  Baseline to week 2

Study Arms (2)

Placebo (left) / Cromoglicate (right)

OTHER

Placebo (on a lesion on left body side), Cromoglicate (on a lesion on right body side)

Drug: Placebo

Placebo (right) / Cromoglicate (left)

OTHER

Placebo (on a lesion on right body side), Cromoglicate (on a lesion on left body side)

Drug: Cromoglicate

Interventions

Cromoglicate DRUG

Twice daily topical treatment for 14 days

Placebo (right) / Cromoglicate (left)

Placebo DRUG

Twice daily topical treatment for 14 days

Placebo (left) / Cromoglicate (right)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent has been obtained
• Age 18 years or above
• Either sex
• Any race or ethnicity
• Attending hospital outpatient clinic or the private practice of a dermatologist
• Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric distribution
• Two treatment areas with a symmetrical distribution each corresponding to 2-3% BSA (Body Surface Area) and each including at least one itchy psoriasis plaque
• 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 analogue scale between each of the two treatment areas
• 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

You may not qualify if:

• 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 randomisation
• adalimumab, infliximab - within 8 weeks prior to randomisation
• ustekinumab - within 16 weeks prior to randomisation
• other products - 4 weeks/5 half-lives (whichever is longer)
• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
• Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
• Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
• antihistamines - within 1 week prior to randomisation
• gabapentin - within 4 weeks prior to randomisation
• PUVA (Psoralen and Ultraviolet A Radiation) or Grenz ray therapy within 4 weeks prior to randomisation.
• UVB therapy within 2 weeks prior to randomisation
• 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
• Subjects with current participation in any other interventional clinical trial
• 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 infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin

Berlin, D-10117, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 24, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)