Trial Outcomes & Findings for Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna (NCT NCT00707174)

NCT ID: NCT00707174

Last Updated: 2013-07-31

Results Overview

Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2013-07-31

Participant Flow

Participant milestones

Measure	Imiquimod Only Topical imiquimod group: treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.	Imiquimod and Tazarotene Combined Topical imiquimod and topical tazarotene 0.1% cream group: Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
Overall Study STARTED	46	44
Overall Study COMPLETED	41	37
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Imiquimod Only Topical imiquimod group: treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.	Imiquimod and Tazarotene Combined Topical imiquimod and topical tazarotene 0.1% cream group: Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
Overall Study Adverse Event	1	6
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna

Baseline characteristics by cohort

Measure	Imiquimod Only n=46 Participants Topical imiquimod group: treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.	Imiquimod and Tazarotene Combined n=44 Participants Topical imiquimod and topical tazarotene 0.1% cream group: Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.	Total n=90 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	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Age Continuous	67.87234 years STANDARD_DEVIATION 13.07606 • n=5 Participants	67.40909 years STANDARD_DEVIATION 11.99286 • n=7 Participants	67.64 years STANDARD_DEVIATION 12.49655 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	44 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All evaluable patients from both groups were compared

Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.

Outcome measures

Measure	Imiquimod Only n=41 Participants Topical imiquimod group: treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.	Imiquimod and Tazarotene Combined n=37 Participants Topical imiquimod and topical tazarotene 0.1% cream group: Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants	27 participants	29 participants

Adverse Events

Imiquimod Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Imiquimod and Tazarotene Combined

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Imiquimod Only n=46 participants at risk Topical imiquimod group: treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.	Imiquimod and Tazarotene Combined n=44 participants at risk Topical imiquimod and topical tazarotene 0.1% cream group: Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
Skin and subcutaneous tissue disorders Inflammatory Response	2.2% 1/46 • Number of events 1 • 5 years	13.6% 6/44 • Number of events 6 • 5 years

Additional Information

Glen Bowen, MD

University of Utah

Phone: 801-581-0255

Email: glen.bown@hci.utah.edu

Results disclosure agreements

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