NCT02051907 (kam1403) is a Phase 2 clinical trial of KAM1403 Gel in Radiation Dermatitis, sponsored by Kamedis Ltd..

Who is sponsoring NCT02051907?

NCT02051907 is sponsored by Kamedis Ltd..

What drugs are being tested in NCT02051907?

Interventions in NCT02051907: KAM1403 Gel, aloevera gel.

What condition does NCT02051907 study?

NCT02051907 studies Radiation Dermatitis.

Is NCT02051907 still recruiting?

NCT02051907 is currently status unknown. Last updated 30 January 2014.

Last reviewed 2014-01-30 · How we verify

NCT02051907: kam1403

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS

Status unknown Phase 2 Last updated 30 January 2014

What this trial tests

Phase 2 trial testing KAM1403 Gel in Radiation Dermatitis in 60 participants. Status unknown.

Timeline

1 March 2014

Primary endpoint
1 March 2015

1 April 2015

Quick facts

Lead sponsor	Kamedis Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 March 2014
Primary completion	1 March 2015
Estimated completion	1 April 2015
Sites	1 location across Israel

Drugs / interventions tested

KAM1403 Gel
aloevera gel — full drug profile →

Conditions studied

Radiation Dermatitis — all drugs for Radiation Dermatitis →

Sponsor

Kamedis Ltd.

Who can join

18 and older, female only, with Radiation Dermatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Changes in Radiation dermatitis symptoms
Time frame: Day 0, weeks 2, 4, 6.5, 8.5
Changes in Radiation dermatitis symptoms assessment during and post radiotherapy (erythema, desquamation, edema, moist desquamation and ulceration) using the Radiation Therapy Oncology Group toxicity scoring system in the treatment group versus the control group

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Radiation Dermatitis

Currently open trials in the same condition.

NCT07086638 — ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer · NA · recruiting
NCT07081074 — ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head · NA · recruiting
NCT07064577 — Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer · NA · recruiting
NCT06915857 — Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Pr · Phase 3 · recruiting
NCT06729814 — Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fracti · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02051907 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kamedis Ltd.
Last refreshed: 30 January 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02051907.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing