Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis (kam1403)

K

Kamedis

Status and phase

Unknown
Phase 2

Conditions

Radiation Dermatitis

Treatments

Device: aloevera gel
Device: KAM1403 Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02051907
KAM-RAD-01

Details and patient eligibility

About

The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female above 18 years of age
  • Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
  • Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
  • Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
  • Minimum of 3 weeks from chemotherapy to start of radiation therapy.
  • Patient agrees to use only the test products during the study period

Exclusion criteria

  • Tumor involvement of the skin
  • Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
  • Patient has a previous history of allergy to the ingredients of the tested formulations
  • Paget's disease of the nipple.
  • Pregnant or lactating females

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

KAM1403 Gel
Experimental group
Description:
A group treated with KAM1403 for the study period.
Treatment:
Device: KAM1403 Gel
Aloevera Gel
Sham Comparator group
Description:
A group treated with Aloevera Gel for the study period
Treatment:
Device: aloevera gel

Trial contacts and locations

0

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Central trial contact

Helena Gryner, M.Sc.

Data sourced from clinicaltrials.gov

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