A double blind randomised controlled trial assessing the effect of 30% topical lidocaine gel on reducing pain in patients presenting to a cosmetic surgery practice with either prominent periorbital or lateral temporal veins for treatment with Neodymium-Doped Yttrium Aluminum Garnet (ND:TAG))

In patients presenting to a cosmetic surgery practice with either prominent periorbital or lateral temporal veins, what is the effect of 30% topical lidocaine gel on pain as assessed on a visual analogue scale compared to placebo?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000996763

Enrollment

Registered

2013-09-09

Start date

2013-07-02

Completion date

2013-08-16

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Some individuals have cosmetically un-pleasing prominent blue veins under their eyes or in their temporal regions. Although there are a number of methods to treat these, a simple, effective and safe method is using a type of laser called ND:YAG which targets the blue pigment in the vein. Unfortunately, patients often describe this as uncomfortable or painful. Therefore, the purpose of this study is to determine if using a lidocaine gel prior to treatment will result in a reduction in pain.

Interventions

1cc volume of topical 30% lidocaine in Lipothene gel (Treatment). This was a split body design such that for each patient, one side of the face received the treatment gel and the other side of the face received the placebo gel. Both the treatment and the placebo gel was applied over prominent veins on the infra-orbit and/or lateral temporal area using a cotton tip applicator. Only veins identified by the surgeon and patient undergoing the treatment was treated with the intervention. The i

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. 18 years of age or older 2. Cosmetically significant lateral temporal or infra-orbital as subjectively judged by the patient

Exclusion criteria

1. known sensitivity or allergy to any topical or other anaesthetic medication 2. unilateral veins only

Outcome results