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Alkagin Paste in the Prevention of Radiation Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01408407
Recruitment Status : Terminated
First Posted : August 3, 2011
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anus Neoplasms Rectal Neoplasms Urogenital Neoplasms Other: Aveeno cream Other: Alkagin paste Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy
Study Start Date : December 2011
Primary Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Other: Aveeno cream
Apply cream on irradiated area twice a day
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.
Other: Aveeno cream
Apply cream on irradiated area twice a day
Other: Alkagin paste
Apply Alkagin paste three times a day.

Outcome Measures

Primary Outcome Measures :
  1. Maximum skin toxicity [ Time Frame: 7 weeks post beginning of radiation treatments ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01408407

Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Dr. Te Vuong
Avario Healthcare Inc.
Principal Investigator: Te Vuong, MD Jewish General Hospital
More Information

Responsible Party: Dr. Te Vuong, MD-Director Radiation Oncology, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01408407     History of Changes
Other Study ID Numbers: 11-052
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015

Keywords provided by Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital:
Patients with anal canal, low rectal or gynecological cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Urogenital Neoplasms
Anus Neoplasms
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Radiation Injuries
Wounds and Injuries
Anus Diseases