A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

223

Participants

Timeline

Start Date

September 11, 2017

Primary Completion Date

November 17, 2017

Study Completion Date

November 17, 2017

Conditions
Tendinopathy
Interventions
DRUG

SM04755

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

OTHER

Vehicle

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

OTHER

White Petrolatum

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

OTHER

Sodium lauryl sulfate

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

Trial Locations (1)

24503

Research Site, Lynchburg

Sponsors
All Listed Sponsors
lead

Biosplice Therapeutics, Inc.

INDUSTRY