Trial Outcomes & Findings for Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis. (NCT NCT01806961)

Results Overview

Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.

Recruitment status

TERMINATED

Target enrollment

16 participants

Primary outcome timeframe

at 6 and 12 months

Results posted on

2016-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	SP848-AK-1101 Patients from SP848-AK-1101 trial
Overall Study STARTED	16
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	SP848-AK-1101 Patients from SP848-AK-1101 trial
Overall Study sponsor decision	16

Baseline Characteristics

Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clearance at End of Trial SP848-AK-1101 n=16 Participants no trial medication during this follow-up trial
Age, Continuous	73 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 6 and 12 months

Population: No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis

Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 and 12 months

clinical examination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 and 12 months

recording of adverse events

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=16 participants at risk Patients from SP848-AK-1101 trial
Skin and subcutaneous tissue disorders Basal cell carcinome lower back	6.2% 1/16 • Number of events 1 • 7 months

Other adverse events

Other adverse events
Measure	Group 1 n=16 participants at risk Patients from SP848-AK-1101 trial
General disorders unspecific inflammation crus helicis left arm	6.2% 1/16 • Number of events 1 • 7 months
Infections and infestations common cold	6.2% 1/16 • Number of events 1 • 7 months
Skin and subcutaneous tissue disorders wart	12.5% 2/16 • Number of events 2 • 7 months
Gastrointestinal disorders oesophageal acid reflux	6.2% 1/16 • Number of events 1 • 7 months
Infections and infestations sinusitis	6.2% 1/16 • Number of events 1 • 7 months
Metabolism and nutrition disorders hypercholesterolemia	6.2% 1/16 • Number of events 1 • 7 months
Vascular disorders carotid stenosis	6.2% 1/16 • Number of events 1 • 7 months

Additional Information

Dr. Francine Santoro

Sipirig AG

Phone: +41 62 387 87 87

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between the PI and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed. 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, PI shall not publish or present Results unless Investigator has submitted to Spirig a draft of the intented publication or presentation for review and approval.
Publication restrictions are in place

Restriction type: OTHER