Allergic Contact EczemaPhase 1NCT01529320
Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
A Phase 1 study testing Adventan® (methylprednisolone aceponate 0,1%) in people with Allergic Contact Eczema, run by Fundacion IMIM at 1 site in Spain.
Trial summary
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Eczema
- What is being tested?
- Adventan® (methylprednisolone aceponate 0,1%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Dermatology Service, Hospital del Mar, Parc de Salut Mar
Barcelona, Barcelona, 08003
About this study
Official title: Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
- Conditions
- Allergic Contact Eczema
- Being tested
- Adventan® (methylprednisolone aceponate 0,1%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adventan® (metilprednisolona aceponato 0,1%) | Experimental | Not described Receives: Drug: Adventan® (methylprednisolone aceponate 0,1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (3)
Erythema intensity by colorimetry.
Measured: 5 days
Eczema intensity by planimetric morphology (ICDRG scale)
Measured: 5 days
VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Contact EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion IMIM
- Sponsor type
- University, hospital or other
- Collaborators
- Adknoma Health Research, Bayer
- Responsible party
- Principal investigator, Ana Maria Gimenez Arnau, Fundacion IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529320
- Sponsor's protocol ID
- GIM-MPA-2011-01
- Other IDs
- 2011-005284-25
- Status last verified
- May 2016
- First submitted
- 6 Feb 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
- ClinicalTrials.gov ID
- NCT01529320
- Acronym / sponsor ID
- GIM-MPA-2011-01
- Conditions
- Allergic Contact Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fundacion IMIMUniversity, hospital or other
- Collaborators
- Adknoma Health Research, Bayer
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adventan® (metilprednisolona aceponato 0,1%) | Experimental | Drug: Adventan® (methylprednisolone aceponate 0,1%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Adventan® (metilprednisolona aceponato 0,1%) |
Primary outcome
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.
3 secondary outcomes
Erythema intensity by colorimetry.
Time frame: 5 days
Eczema intensity by planimetric morphology (ICDRG scale)
Time frame: 5 days
VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adventan® (methylprednisolone aceponate 0,1%) in people with Allergic Contact Eczema, run by Fundacion IMIM at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.