Clinical trial · Interventional
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
NCT01408407CI-TRIAL-00111475terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Urogenital Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alkagin paste | Other | — | UNRESOLVED |
| Aveeno cream | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: standard of care
- description
- 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
- interventionNames
- Other: Aveeno cream
- type
- EXPERIMENTAL
- label
- Arm B: standard of care plus Alkagin paste
- description
- 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.
- interventionNames
- Other: Aveeno cream
- Other: Alkagin paste
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.