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OpenTrials
Completed

NCT Number: NCT01529320

Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dermatology Service, Hospital del Mar, Parc de Salut Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adventan® (methylprednisolone aceponate 0,1%)

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacion IMIM

Other

Collaborators

  • Adknoma Health Research
  • Bayer

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.