Trial Outcomes & Findings for Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (NCT NCT01808950)
NCT ID: NCT01808950
Last Updated: 2016-06-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
8 weeks after a maximal treatment period of 4 weeks
Results posted on
2016-06-22
Participant Flow
Participant milestones
| Measure |
0.06% Resiquimod Gel - A
* 60 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A
|
0.06% Resiquimod Gel - B
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B
|
0.06% Resiquimod Gel - C
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
* The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
0
|
|
Overall Study
COMPLETED
|
1
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
0.06% Resiquimod Gel - A
n=1 Participants
* 60 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A
|
0.06% Resiquimod Gel - B
n=3 Participants
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B
|
0.06% Resiquimod Gel - C
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
* The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
0 participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
0 participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
—
|
4 participants
n=4 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
—
|
1 participants
n=4 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
—
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
—
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after a maximal treatment period of 4 weeksPopulation: data were not collected for any of study participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks after the 4 weeks treatment periodPopulation: data were not collected for any of study participant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 weekslocal skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks after a maximal treatment period of 4 weeksOutcome measures
Outcome data not reported
Adverse Events
0.06% Resiquimod Gel - A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.06% Resiquimod Gel - B
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
0.06% Resiquimod Gel - C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.06% Resiquimod Gel - A
n=1 participants at risk
* 60 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A
|
0.06% Resiquimod Gel - B
n=3 participants at risk
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B
|
0.06% Resiquimod Gel - C
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
* The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Mutlilocular BCC right had Prox.
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Nodular BCC arm left
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
superficial BCC submammary
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
Other adverse events
| Measure |
0.06% Resiquimod Gel - A
n=1 participants at risk
* 60 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A
|
0.06% Resiquimod Gel - B
n=3 participants at risk
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B
|
0.06% Resiquimod Gel - C
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
* The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
exertional dyspnoea
|
100.0%
1/1 • Number of events 1
|
0.00%
0/3
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
cornu cutaneum
|
0.00%
0/1
|
33.3%
1/3 • Number of events 1
|
—
0/0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator is granted a right to publish and present Trial Results together with other investigators of Trial and to be referred to in publications containing such results. However, investigator shall not publish or present Trial Results unless Investigator has submitted to Spirig a draft of the intended publication or presentation for review and approval.
- Publication restrictions are in place
Restriction type: OTHER