PainPhase 1NCT01055249
UVB Model Validation Study
A Phase 1 study testing Ibuprofen, Hydrocortisone and Hydrocortisone in people with Pain and Inflammation, run by X-pert Med GmbH at 1 site in Germany.
Trial summary
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammation, Healthy Volunteers
- What is being tested?
- Ibuprofen, Hydrocortisone and Hydrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jun 2010
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Centre, Subject and Observer Blinded, Placebo Controlled, Cross-over Study of the Effect of Oral Ibuprofen and Topical Hydrocortisone-21-acetate on Ultraviolet Radiation (UVR) Induced Pain and Inflammation in Healthy Volunteers
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.
Read the detailed description
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.
Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine MED will be done within 24 h after UVR.
A training session (without study medication) using the MED definition areas will be performed in order to introduce subjects to the testing and rating procedures.
Subjects will come in within 14 days of screening to start the first Segment of the study. Eligible subjects will be randomised to receive either:
- IB 600 mg, applied orally b.i.d., or
- OP, applied orally b.i.d.
Allocation of topical treatment to these areas will be randomly assigned to:
- PG, 15 μl/cm2 applied topically b.i.d., or
- HC, 15 μl/cm2 applied topically b.i.d.
Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.
Subjects return within 4 to 11 days to the study site for the second segment of the study. Treatment allocation will be crossed-over and new treatment areas will be selected on the back.
- Conditions
- Pain, Inflammation, Healthy Volunteers
- Being tested
- Ibuprofen, Hydrocortisone, Hydrocortisone
- Keywords
- UVB, pain, inflammation, model, healthy volunteers, Ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen, HydrocortisoneDrug
Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
HydrocortisoneDrug
Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) Receives: Drug: Ibuprofen, Hydrocortisone |
| Group B | Other | Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperalgesia to heat
Measured: 72 h
Secondary outcomes (1)
Erythema, Skin temperature
Measured: 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- X-pert Med GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055249
- Sponsor's protocol ID
- XPM-024
- Status last verified
- Jul 2010
- First submitted
- 22 Jan 2010
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre, Subject and Observer Blinded, Placebo Controlled, Cross-over Study of the Effect of Oral Ibuprofen and Topical Hydrocortisone-21-acetate on Ultraviolet Radiation (UVR) Induced Pain and Inflammation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01055249
- Acronym / sponsor ID
- XPM-024
- Conditions
- Pain, Inflammation, Healthy Volunteers
- Keywords
- UVB, pain, inflammation, model, healthy volunteers, Ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- X-pert Med GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- First posted
- 25 Jan 2010 (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.
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.
Detailed description
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.
Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine MED will be done within 24 h after UVR.
A training session (without study medication) using the MED definition areas will be performed in order to introduce subjects to the testing and rating procedures.
Subjects will come in within 14 days of screening to start the first Segment of the study. Eligible subjects will be randomised to receive either:
- IB 600 mg, applied orally b.i.d., or
- OP, applied orally b.i.d.
Allocation of topical treatment to these areas will be randomly assigned to:
- PG, 15 μl/cm2 applied topically b.i.d., or
- HC, 15 μl/cm2 applied topically b.i.d.
Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.
Subjects return within 4 to 11 days to the study site for the second segment of the study. Treatment allocation will be crossed-over and new treatment areas will be selected on the back.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Ibuprofen, HydrocortisoneIbuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) |
| Group B | Other | Drug: HydrocortisoneOral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ibuprofen, HydrocortisoneIbuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d. | Drug | Group A |
| HydrocortisoneHydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d. | Drug | Group B |
Primary outcome
Hyperalgesia to heat
Time frame: 72 h
1 secondary outcome
Erythema, Skin temperature
Time frame: 72 h
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 13 Jul 2010.
- link to Sponsor and investigational siteLink provided by the sponsor.
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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 Ibuprofen, Hydrocortisone and Hydrocortisone in people with Pain and Inflammation, run by X-pert Med GmbH at 1 site in Germany.
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 1 inclusion and 1 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 13 Jul 2010. 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 Germany. 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?
Hyperalgesia to heat (time frame: 72 h). 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 13 Jul 2010.