Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
2 other identifiers
interventional
18
1 country
1
Brief Summary
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 12, 2016
May 1, 2016
3 months
February 6, 2012
May 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.
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.
5 days
Secondary Outcomes (3)
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
Study Arms (1)
Adventan® (metilprednisolona aceponato 0,1%)
EXPERIMENTALInterventions
Doses: 1/4 FTU (Finger Tip Unit) during 5 days (Day 7-Day 11). Procedure: Patch Test (Nickel sulphate 5%) during 2 days (Day 0- Day 2.
Eligibility Criteria
You may qualify if:
- 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.
- Able and willing to comply with protocol procedures and to follow the investigator's instructions.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion IMIMlead
- Adknoma Health Researchcollaborator
- Bayercollaborator
Study Sites (1)
Dermatology Service, Hospital del Mar, Parc de Salut Mar
Barcelona, Barcelona, 08003, Spain
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 8, 2012
Study Start
February 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 12, 2016
Record last verified: 2016-05