Trial Outcomes & Findings for Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old (NCT NCT01574612)

Last Updated: 2014-05-22

Results Overview

treatment period is for 5 days and follow up visits at 7days and 21 days after first dose

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

54 participants

Primary outcome timeframe

day 1 to day 21

Results posted on

2014-05-22

Participant milestones
Measure	Topical Cream commercial product being used acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days
Overall Study STARTED	54
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	8

Reasons for withdrawal
Measure	Topical Cream commercial product being used acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days
Overall Study Adverse Event	3
Overall Study non compliant with drug	2
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2

Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old

Baseline characteristics by cohort
Measure	Topical Cream n=54 Participants xerese topical cream is the only active used in this trial
Age, Continuous	9.1 years STANDARD_DEVIATION 1.7 • n=5 Participants
Age, Categorical <=18 years	54 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants
age of subjects with prior history of herpes labialis outbreak less than or equal to 3 years	27 participants 33 • n=5 Participants
age of subjects with prior history of herpes labialis outbreak age 4 to 6 years	17 participants 21.5 • n=5 Participants
age of subjects with prior history of herpes labialis outbreak age 7 to 9 years	10 participants 13.9 • n=5 Participants

Timeframe: day 1 to day 21

treatment period is for 5 days and follow up visits at 7days and 21 days after first dose

Outcome measures
Measure	Topical Cream n=54 Participants commercial cream used
Reporting of Adverse Events	9 participants

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Topical Cream n=54 participants at risk commercial product being used acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days
General disorders general disorder	1.9% 1/54
Infections and infestations URI	5.6% 3/54
Injury, poisoning and procedural complications lip injury	3.7% 2/54
Gastrointestinal disorders paresthesia oral	1.9% 1/54
Skin and subcutaneous tissue disorders rash	1.9% 1/54
Nervous system disorders headache	1.9% 1/54

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