Investigation of the antihyperalgesic effect of topical buprenorphine in an UV-B induced inflammatory skin pain model in healthy volunteers - topical buprenorphine in sunburn

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002159-41-AT

Enrollment

Registered

2005-11-03

Start date

2005-10-03

Completion date

Unknown

Last updated

2013-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volunteer study with healthy volunteers using the UV-B-model as model of hyperalgesia.

Interventions

Product Name: buprenorphine Pharmaceutical Form: Cutaneous emulsion INN or Proposed INN: buprenorphine Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 16 healthy volunteers (both male and female, 1:1) will be included in the study. Age 19-40 yrs., body mass index between 19 and 29, drug free, pain free. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy, any disease, ongoing pain, previous exposure to UV-light (sun exposure)

Design outcomes

Primary

Measure	Time frame
Main Objective: In this study the following hypotheses will be tested: · Topical buprenorphine increases the heat pain threshold in the UV-B induced hyperalgesia of the skin compared to vehicle. · This effect is dose dependent in a dose range between 0.01 and 0.04 % buprenorphine cream. ;Secondary Objective: To test the study drug concerning secondary outcome variables: · Cold pain perception threshold (CPPT) in the inflamed area and in normal skin · Stimulus response to different moving innocuous stimuli (Q-tip, cotton wisp, soft brush) in the inflamed area and in normal skin · Heat pain tolerance threshold (HPTT) in the inflamed area and in normal skin. ;Primary end point(s): Heat pain threshold after 1 hour of treatment with buprenorphine cream in the sunburn.	—

Measure

Time frame

Main Objective: In this study the following hypotheses will be tested: · Topical buprenorphine increases the heat pain threshold in the UV-B induced hyperalgesia of the skin compared to vehicle. · This effect is dose dependent in a dose range between 0.01 and 0.04 % buprenorphine cream. ;Secondary Objective: To test the study drug concerning secondary outcome variables: · Cold pain perception threshold (CPPT) in the inflamed area and in normal skin · Stimulus response to different moving innocuous stimuli (Q-tip, cotton wisp, soft brush) in the inflamed area and in normal skin · Heat pain tolerance threshold (HPTT) in the inflamed area and in normal skin. ;Primary end point(s): Heat pain threshold after 1 hour of treatment with buprenorphine cream in the sunburn.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026