Randomized, placebo-controlled, double-blind trial to study the effects of polidocanol on experimental pruritus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004279

Enrollment

Registered

2012-09-03

Start date

2012-09-03

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

L29

Interventions

Group 1: topical 3% polidocanol solution, one time application to the skin as spray, about 1ml in total

histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds Group 2: placebo, one time application to the skin as spray, about 1ml in total

histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy individuals

Exclusion criteria

Exclusion criteria: Pregnancy, breast feeding, skin diseases, diseases of the peripheral nervous system, intake of antihistamines, NSAIDs, local anesthetics or mast cell stabilizers within 5 days prior to testing, intake of antideppressants within 14 days prior to testing, intake of steroids (topical or systemic) within 7 days prior to testing.

Design outcomes

Primary

Measure	Time frame
To assess the effect of 3% Polidocanol on pruritus induced by Mucuna pruriens (cowhage) by itch intensity (VAS) within 30 minutes after Mucuna application	—

Secondary

Measure	Time frame
- To assess the effect of 3% Polidocanol on pruritus induced by histamine (by VAS for 30 minutes) - To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by Mucuna pruriens (cowhage). Wheal development will be assessed by measuring wheal diameter (mean of the largest diameter and the perpendicular diameter) and volumetry of the wheal using digital volumetric measurements 15 and 30 minutes after provocation. Flare will be measured in extent by measuring flare diameter (mean of the largest diameter and the perpendicular diameter) and in intensity using a mexameter 15 and 30 minutes after provocation. - To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by histamine as described above	—

Measure

Time frame

- To assess the effect of 3% Polidocanol on pruritus induced by histamine (by VAS for 30 minutes) - To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by Mucuna pruriens (cowhage). Wheal development will be assessed by measuring wheal diameter (mean of the largest diameter and the perpendicular diameter) and volumetry of the wheal using digital volumetric measurements 15 and 30 minutes after provocation. Flare will be measured in extent by measuring flare diameter (mean of the largest diameter and the perpendicular diameter) and in intensity using a mexameter 15 and 30 minutes after provocation. - To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by histamine as described above

—

Countries

Germany

Contacts

Public ContactHesna Gözlükaya

Klinik für Dermatologie und Allergologie Charité - Universitätsmedizin Berlin

hesna.goezluekaya@charite.de+49 30 450 618296

Outcome results

None listed

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