Fractional CO2 laser assisted delivery of topical anesthetics: a randomized controlled pilot study

Fractional CO2 laser assisted delivery of topical anesthetics: a randomized controlled pilot study - Fractional laser assisted delivery of anesthetics

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40699

Enrollment

Registered

2014-08-04

Start date

2014-09-18

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Not applicable

Interventions

In each subject, four test regions on subject*s back of 1x1 centimeter will be randomly allocated in a 2x2 design to (1) ablative fractional laser (AFXL) pretreatment (5% density, 2.5 mJ/microbeam)

10: worst imaginable pain) directly after each pain stimulus.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Fitzpatrick skin type I or II Age *18 years Patient is willing and able to give written informed consent

Exclusion criteria

Exclusion criteria: History of keloid or hypertrophic scar formation or complicated wound healing Presence of any active skin disease Known allergy to local anesthesia Pregnancy or lactation Incompetency to understand what the procedure involves Current complaints of chronic pain or other alterations in pain sensation (e.g. due to diabetes mellitus or lepra) Current treatment with systemic analgesics or other medication that can influence pain sensation Current treatment with anticoagulants Fitzpatrick skin type III-VI Excessive sun tan

Design outcomes

Primary

Measure	Time frame
The main study parameter is pain, as scored on a VAS from 0-10 (0: no pain; 10: worst imaginable pain) directly after each pain stimulus.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)