Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01529320
NCT01529320CompletedPhase 1

Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).

Fundacion IMIM1 site in 1 country18 target enrollmentStarted: February 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
18
Locations
1
Primary Endpoint
Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subjects ≥18 years old.
  • •Subjects with a history of diagnosis of sensitization to Nickel sulphate.
  • •Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.
  • •Skin Phototype II-III.
  • •Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.
  • •Written informed consent prior to inclusion.
  • •Able and willing to comply with protocol procedures and to follow the investigator's instructions.
  • •Criteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.

Exclusion Criteria

  • •Active cutaneous disease causing itch (active eczema, urticaria or insect bites)
  • •Active systemic disease that may induce itch (hepatic or renal disease).
  • •Active psychiatric disease that could interfere with symptom assessment.
  • •Treatment with drugs inducing itch.
  • •Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.
  • •Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.
  • •Active skin disease in the back that may interfere with the assessment of response to topical application of allergen
  • •Pregnancy or lactation
  • •Subjects with contraindications specified in Summary of Product Characteristics (SPC).

Arms & Interventions

Adventan® (metilprednisolona aceponato 0,1%)

Experimental

Intervention: Adventan® (methylprednisolone aceponate 0,1%) (Drug)

Outcomes

Primary Outcomes

Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.

Time Frame: 5 days

Time to Itch Relief is defined as the time needed to reach a 30% decrease of the maximum VAS (Visual Analogue Scale used for self-assessment of itch by the volunteers) recorded after the start of treatment.

Secondary Outcomes

  • Erythema intensity by colorimetry.(5 days)
  • Eczema intensity by planimetric morphology (ICDRG scale)(5 days)
  • VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)(5 days)

Investigators

Sponsor
Fundacion IMIM
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ana Maria Gimenez Arnau

MD

Fundacion IMIM

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.Chickenpox
NCT05732337Karo Pharma AB28
Completed
Not Applicable
A pilot study towards a therapy with prednisolone encapsulated liposomes for the treatment of Graves' Orbitopathy with reduced systemic steroid exposureActive GO (CAS 3 &#82107).
NL-OMON24926Het Oogziekenhuis Rotterdam /Rotterdam Ophthalmic Institute<br>PO Box 70030, NL-3000 LM Rotterdam<br>Telephone: +31 (0) 10 4023 44920
Completed
Early Phase 1
Methylprednisolone Treatment of Friedreich AtaxiaFriedreich Ataxia
NCT02424435Children's Hospital of Philadelphia11
Completed
Not Applicable
Topical methylprednisolone aceponate in an induced eczema modelPruritus
DRKS00005608Charité Campus Charité Mitte31
Completed
Phase 1
A Study to Evaluate the Irritation Potential of ATx201 in Healthy VolunteersIrritation Potential of Topic Agent
NCT03301870UNION therapeutics36