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NCT01529320
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Phase 1 trial testing Adventan® (methylprednisolone aceponate 0,1%) in Allergic Contact Eczema in 18 participants. Completed in 1 May 2012.
1 May 2012
Quick facts
| Lead sponsor | Fundacion IMIM |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 18 |
| Start date | 1 February 2012 |
| Primary completion | 1 May 2012 |
| Estimated completion | 1 May 2012 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Adventan® (methylprednisolone aceponate 0,1%) — full drug profile →
Conditions studied
- Allergic Contact Eczema — all drugs for Allergic Contact Eczema →
Sponsor
Fundacion IMIM — full company profile →
Who can join
18 and older, any sex, with Allergic Contact Eczema. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01529320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01529320 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacion IMIM
- Last refreshed: 11 May 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01529320.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing