Trial Outcomes & Findings for Imiquimod for Preventing Keloid Recurrence (NCT NCT03760250)

NCT ID: NCT03760250

Last Updated: 2020-11-19

Results Overview

To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 weeks after surgical excision
• Results posted on: 2020-11-19

Participant Flow

Participant milestones

Measure	Imiquimod 5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Imiquimod 5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Imiquimod for Preventing Keloid Recurrence

Baseline characteristics by cohort

Measure	Imiquimod n=6 Participants 5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after surgical excision

To assess the efficacy of 5% Imiquimod cream on decreasing keloid recurrence after excision when initiated prior to excision

Outcome measures

Measure	Imiquimod n=4 Participants 5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Keloid Recurrence Recurred	3 Participants
Keloid Recurrence Did not recur	1 Participants

SECONDARY outcome

Timeframe: 12 weeks after surgical excision

tolerability of 5% imiquimod cream - clinical evaluation of local site reactions by clinicians for symptoms such as redness, discomfort, swelling, and ulceration at the site of drug application on the following scale with none being the best and severe the worst: none (no reaction in application site), mild (slight redness in application site), moderate (redness with swelling and pain in application site), severe (redness, swelling, ulceration in application site)

Outcome measures

Measure	Imiquimod n=4 Participants 5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
Tolerability - Local Site Reaction Rated on a Scale local site reaction: mild	4 Participants
Tolerability - Local Site Reaction Rated on a Scale local site reaction: none	0 Participants
Tolerability - Local Site Reaction Rated on a Scale local site reaction: moderate	0 Participants
Tolerability - Local Site Reaction Rated on a Scale local site reaction: severe	0 Participants

Adverse Events

Imiquimod

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

Jenny Wei

University of Pennsylvania

Phone: 2153165151

Email: jenny.wei@pennmedicine.upenn.edu

Results disclosure agreements

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