NCT02257281

Brief Summary

The purposes of study are to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

October 2, 2014

Last Update Submit

December 13, 2015

Conditions

Inflammation

Keywords

Sodium lauryl sulfateSkin irritantsinflammationtherapeutic ultrasound

Outcome Measures

Primary Outcomes (1)

  • skin blood flow

    2 weeks

Secondary Outcomes (5)

  • skin temperature

    2 weeks

  • skin water content

    2 weeks

  • Tactile pain threshold

    2 weeks

  • erythema index

    2 weeks

  • skin thickness

    2 weeks

Study Arms (2)

Active Therapeutic Ultrasound

EXPERIMENTAL

The three inflammatory forearm spots on the same side induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with active therapeutic ultrasound .

Device: Active Therapeutic Ultrasound

Non-active Therapeutic Ultrasound

PLACEBO COMPARATOR

The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound .

Device: Non-active Therapeutic Ultrasound

Interventions

Active Therapeutic UltrasoundDEVICE

For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.

Active Therapeutic Ultrasound
Non-active Therapeutic UltrasoundDEVICE

For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.

Non-active Therapeutic Ultrasound

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • asia healthy subjects
  • aged 20-45 years

You may not qualify if:

  • disadvantaged groups
  • systemic disease, such as DM, cancer, autoimmune disorder
  • hyperhidrosis or hypothyroidism
  • a past history of dermatitis
  • active infective or inflammatory cutaneous disease
  • smoking or drinking
  • take medicine, over sun exposure, exercise or menstruation during experimental period
  • contraindication of therapeutic ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peir Renn Wang, MD

    Department of rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chung Shan Medical University

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12