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Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529320
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : May 12, 2016
Adknoma Health Research
Information provided by (Responsible Party):
Ana Maria Gimenez Arnau, Fundacion IMIM

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Study Start Date : February 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Erythema intensity by colorimetry. [ Time Frame: 5 days ]
  2. Eczema intensity by planimetric morphology (ICDRG scale) [ Time Frame: 5 days ]
  3. VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT) [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529320

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

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Responsible Party: Ana Maria Gimenez Arnau, MD, Fundacion IMIM Identifier: NCT01529320     History of Changes
Other Study ID Numbers: GIM-MPA-2011-01
2011-005284-25 ( EudraCT Number )
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Methylprednisolone aceponate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Trace Elements
Growth Substances