Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)

A Randomized, Double Blind, Placebo Controlled, Crossover Clinical Trial to Evaluate the Effects of ATP-Induced Pain (AIP) and ATP-induced Dermal Vasodilation (AIDV) by Iontophoresis in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00917696

Enrollment

Registered

2009-06-10

Start date

2009-10-31

Completion date

2011-06-30

Last updated

2015-07-30

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

Conditions

Osteoarthritis Pain

Brief summary

This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as target engagement tools for future development of analgesics.

Interventions

PROCEDUREComparator: Iontophoresis and Laser Doppler with ATP

Iontophoresis treatments with 10 mM ATP (adenosine triphosphate) solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.

PROCEDUREComparator: Iontophoresis and Laser Doppler with Saline

Iontophoresis treatments with 20 mM saline solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is in generally good health * Subject is willing to abstain from smoking within 24 hours of each iontophoresis treatment and limit smoking to 5 or less cigarettes per week during the study

Exclusion criteria

* Subject has a history of dermatitis, psoriasis, or eczema * Subject has active asthma and/or hay fever at the time of the screening visit * Subject is unable to refrain from use of analgesics within 3 days prior to each treatment period

Design outcomes

Primary

Measure	Time frame
Degree of pain induced by ATP vs. saline iontophoresis	4 minutes
Increase in blood flow induced by ATP iontophoresis	8 minutes

Secondary

Measure	Time frame
Test-retest reproducibility and intra-subject variability of AIP and AIDV	8 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026