Trial Outcomes & Findings for Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT (NCT NCT01931150)

NCT ID: NCT01931150

Last Updated: 2017-01-13

Results Overview

Change from Baseline in the Number of Lesions at 28 days

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 11 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-01-13

Participant Flow

Participant milestones

Measure	Dapsone LEFT, Moisturizer RIGHT Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.	Dapsone RIGHT, Moisturizer LEFT Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
Overall Study STARTED	5	6
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Dapsone LEFT, Moisturizer RIGHT Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.	Dapsone RIGHT, Moisturizer LEFT Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT

Baseline characteristics by cohort

Measure	Dapsone LEFT, Moisturizer RIGHT n=5 Participants Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.	Dapsone RIGHT, Moisturizer LEFT n=6 Participants Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Change from Baseline in the Number of Lesions at 28 days

Outcome measures

Measure	Dapsone LEFT, Moisturizer RIGHT n=4 Participants Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.	Dapsone RIGHT, Moisturizer LEFT n=4 Participants Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions	4 participants	4 participants

Adverse Events

Dapsone LEFT, Moisturizer RIGHT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dapsone RIGHT, Moisturizer LEFT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dapsone LEFT, Moisturizer RIGHT n=5 participants at risk Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.	Dapsone RIGHT, Moisturizer LEFT n=6 participants at risk Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
General disorders Allergic reaction	0.00% 0/5	16.7% 1/6

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mario Lacouture

Memorial Sloan Kettering Cancer Center

Phone: 646-888-6014

Email: LacoutuM@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place