Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

This study has been completed.
Sponsor:
Collaborators:
Adknoma Health Research
Bayer
Information provided by (Responsible Party):
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01529320
First received: February 6, 2012
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Allergic Contact Eczema
Drug: Adventan® (methylprednisolone aceponate 0,1%)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).

Resource links provided by NLM:


Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Erythema intensity by colorimetry. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Eczema intensity by planimetric morphology (ICDRG scale) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adventan® (metilprednisolona aceponato 0,1%) Drug: Adventan® (methylprednisolone aceponate 0,1%)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects ≥18 years old.
  2. Subjects with a history of diagnosis of sensitization to Nickel sulphate.
  3. Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.
  4. Skin Phototype II-III.
  5. Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.
  6. Written informed consent prior to inclusion.
  7. 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:

  1. Active cutaneous disease causing itch (active eczema, urticaria or insect bites)
  2. Active systemic disease that may induce itch (hepatic or renal disease).
  3. Active psychiatric disease that could interfere with symptom assessment.
  4. Treatment with drugs inducing itch.
  5. Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.
  6. Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.
  7. Active skin disease in the back that may interfere with the assessment of response to topical application of allergen
  8. Pregnancy or lactation
  9. Subjects with contraindications specified in Summary of Product Characteristics (SPC).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529320

Locations
Spain
Dermatology Service, Hospital del Mar, Parc de Salut Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Fundacion IMIM
Adknoma Health Research
Bayer
  More Information

No publications provided

Responsible Party: Fundacion IMIM
ClinicalTrials.gov Identifier: NCT01529320     History of Changes
Other Study ID Numbers: GIM-MPA-2011-01, 2011-005284-25
Study First Received: February 6, 2012
Last Updated: September 25, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Dermatitis, Contact
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone aceponate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014