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Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast

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ClinicalTrials.gov Identifier: NCT01017315
Recruitment Status : Unknown
Verified May 2012 by Boonsin Tangtrakulwanich, Prince of Songkla University.
Recruitment status was:  Enrolling by invitation
First Posted : November 20, 2009
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients.

The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively.

Pruritus score and satisfaction will be monitor along the entire course of cast retention.

Condition or disease Intervention/treatment Phase
Fracture Distal Radius Drug: Baby talcum Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial
Study Start Date : July 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: No application of baby talcum
Drug: Baby talcum
50 grams apply locally prior cast application
Other Name: "Care" brand of baby talcum

Outcome Measures

Primary Outcome Measures :
  1. Pruritus score [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Satisfaction score [ Time Frame: 2 years ]
  2. Complication rate [ Time Frame: 2 years ]
  3. Number of antihistamine drugs used [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Fracture distal end radius treated conservatively

Exclusion Criteria:

  • open fracture
  • skin disease and wound under cast area
  • Fracture distal end radius needed surgical management
  • Allergy to baby talcum
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017315

Prince of Songkla university
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D Prince of Songkla University
More Information

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017315     History of Changes
Other Study ID Numbers: 52-197-11-4-2
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Boonsin Tangtrakulwanich, Prince of Songkla University:
baby talcum

Additional relevant MeSH terms:
Skin Diseases
Skin Manifestations
Signs and Symptoms