Trial Outcomes & Findings for Topical Use of Difinsa53™ to Prevent Radiation Dermatitis (NCT NCT02534129)

Results Overview

A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-10-06

Participant Flow

13 patients were entered, each of whom had a single radiation port divided into two fields. One received aquaphor protection and the other received Difinsa53 protection.

Unit of analysis: Radiation fields

Participant milestones

Participant milestones
Measure	Aquaphor This radiation field treated with aquaphor	Difinsa53 This radiation field treated with Difinsa53
Overall Study STARTED	13 13	13 13
Overall Study COMPLETED	13 13	13 13
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Difinsa53 and Aquaphor Arms n=13 Participants Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Difinsa53: Difinsa53 cream is applied to one half of radiation field Aquaphor: Aquaphor is applied to one half of radiation field
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Participants · Female	13 Participants n=5 Participants
Sex: Female, Male Participants · Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All patients were analyzed by blinded observor

A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.

Outcome measures

Outcome measures
Measure	Difinsa 53 Arm n=13 Participants Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Difinsa53: Difinsa53 cream is applied to one half of radiation field	Aquaphor Arm n=13 Participants Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Aquaphor: Aquaphor is applied to one half of radiation field
Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 1.0

Adverse Events

Difinsa53 Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aquaphor Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

L. Michael Glode, MD

ProTechSure Scientific Inc.

Phone: 303-526-9031

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place