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Alkagin Paste in the Prevention of Radiation Dermatitis

This study has been terminated.
Sponsor:
Collaborator:
Avario Healthcare Inc.
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01408407
First received: August 2, 2011
Last updated: June 3, 2014
Last verified: June 2014

August 2, 2011
June 3, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
Maximum skin toxicity [ Time Frame: 7 weeks post beginning of radiation treatments ] [ Designated as safety issue: Yes ]
The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of Alkagin Paste compared to patients treated with institutional standard skin care.
Same as current
Complete list of historical versions of study NCT01408407 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Alkagin Paste in the Prevention of Radiation Dermatitis
A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy

The purpose of this study is to determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Anus Neoplasms
  • Rectal Neoplasms
  • Urogenital Neoplasms
  • Other: Aveeno cream
    Apply cream on irradiated area twice a day
  • Other: Alkagin paste
    Apply Alkagin paste three times a day.
  • Active Comparator: Arm A: standard of care
    Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatment
    Intervention: Other: Aveeno cream
  • Experimental: Arm B: standard of care plus Alkagin paste
    Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment.
    Interventions:
    • Other: Aveeno cream
    • Other: Alkagin paste
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients receiving a dose of 45 Gy or more with concomitant chemotherapy to the perineal skin (for treatment of anal canal, low rectal or gynecological cancer).
  • Patients able to understand and sign an informed consent form.
  • Patients that do not have active connective tissue disorders.
  • Patients 18 years or older.
  • Patients that did not receive any previous radiation.
  • Patients that do not have any known allergy to any ingredients of the Alkagin Paste
  • Patients need to be able to apply the creams themselves or have help with applying the creams.
  • Patients who have been offered to purchase silver clear underpants but have refused

Exclusion Criteria:

  • Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it)

The Fitzpatrick Scale:

  • Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
  • Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
  • Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
  • Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease
  • Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
  • Type VI Black. Never burns, tans very easily

    2) Patients with an allergic reaction to Alkagin Paste

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01408407
11-052
No
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
Dr. Te Vuong
Avario Healthcare Inc.
Principal Investigator: Te Vuong, MD Jewish General Hospital
Sir Mortimer B. Davis - Jewish General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP