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An Open, Uncontrolled Study of GK567 for Malodorous Fungating Neoplastic Tumours

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01541930
First received: February 24, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours in 25 subjects, over 14 days of treatment.


Condition Intervention Phase
Malodorous Infected Cutaneous Ulcer
 Drug: GK567
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Uncontrolled Study Investigating the Safety and Efficacy of GK567 in the Deodorization of Malodorous Infected Cutaneous Fungating Neoplastic Tumours, Over 14 Days of Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • The success rate, where success for a patient is defined as a smell score of 0 or 1 as assessed by the Study Investigator [ Time Frame: at Day 14 (end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smell score [ Time Frame: at Day 14 (end of treatment) ] [ Designated as safety issue: No ]
  • Appearance [ Time Frame: at Day 14 (end of treatment) ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: at Day 14 (end of treatment) ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GK567 Drug: GK567
Once or twice daily, for 14 days, up to 30 g per day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a male or female aged between 20 years or older.
  • The subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the Study investigator's assessment)

Exclusion Criteria:

  • The subject is currently receiving systemic antibiotics or received in the last 2 weeks,
  • The subject is currently receiving systemic or topical Metronidazole or received in the last week,
  • The subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week,
  • The subject already receives any topical treatment on the cutaneous fungating neoplastic tumour
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541930

Locations
Japan
Galderma investigational site
Kanagawa, Japan
Galderma investigational site
Tokyo, Japan
Sponsors and Collaborators
Galderma R&D
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01541930     History of Changes
Other Study ID Numbers: RDT.07.SPR.27013
Study First Received: February 24, 2012
Last Updated: February 12, 2013
Health Authority: Japan: MHLW (Ministry of Health, Labour and Welfare)

Additional relevant MeSH terms:
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013