Trial Outcomes & Findings for Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars (NCT NCT01689857)

Results Overview

Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables. * vascularity(range from normal(0 point) to purple(3point) * pigmentation(range from normal(0 point) to hyper-pigmentation(3point) * pliability(range from normal(0 point) to contracture(5point) * height (range from flat(0 point) to above 5mm(3point) * pain(range from none(0 point) to Require medication(2point) * itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2013-04-15

Participant Flow

This study was conducted at Seoul National University Bundang hospital. Forty subjects were recruited from May, 2010 to April,2012.

In this study, we had no run-in period before study was commenced and there were no subjects who drop out before enrollment and randomization to groups.

Participant milestones

Participant milestones
Measure	Scarclinic™ Thin Scarclinic™ Thin applied on the surgical scar for 12weeks	Scarclinic™ Normal Scarclinic™ Normal applied on the surgical scar for 12weeks
Overall Study STARTED	20	20
Overall Study COMPLETED	15	18
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Scarclinic™ Thin Scarclinic™ Thin applied on the surgical scar for 12weeks	Scarclinic™ Normal Scarclinic™ Normal applied on the surgical scar for 12weeks
Overall Study Lost to Follow-up	5	2

Baseline Characteristics

Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scarclinic™ Thin n=20 Participants Scarclinic™ Thin applied on the surgical scar for 12weeks	Scarclinic™ Normal n=20 Participants Scarclinic™ Normal applied on the surgical scar for 12weeks	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	39.90 years STANDARD_DEVIATION 10.47 • n=5 Participants	36.00 years STANDARD_DEVIATION 9.93 • n=7 Participants	37.95 years STANDARD_DEVIATION 10.26 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Korea, Republic of	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.

Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables. * vascularity(range from normal(0 point) to purple(3point) * pigmentation(range from normal(0 point) to hyper-pigmentation(3point) * pliability(range from normal(0 point) to contracture(5point) * height (range from flat(0 point) to above 5mm(3point) * pain(range from none(0 point) to Require medication(2point) * itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.

Outcome measures

Outcome measures
Measure	Scarclinic™ Thin n=15 Participants Scarclinic™ Thin applied on the surgical scar for 12weeks	Scarclinic™ Normal n=18 Participants Scarclinic™ Normal applied on the surgical scar for 12weeks
Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months	-3.80 units on a scale Standard Deviation 3.02	-2.61 units on a scale Standard Deviation 2.63

SECONDARY outcome

Timeframe: the end of the 3 month of the treatment

Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire

Outcome measures

Outcome data not reported

Adverse Events

Scarclinic™ Thin

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Scarclinic™ Normal

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Scarclinic™ Thin n=20 participants at risk Scarclinic™ Thin applied on the surgical scar for 12weeks	Scarclinic™ Normal n=20 participants at risk Scarclinic™ Normal applied on the surgical scar for 12weeks
Skin and subcutaneous tissue disorders itching sense	50.0% 10/20 • Number of events 10	40.0% 8/20 • Number of events 8
Skin and subcutaneous tissue disorders redness	10.0% 2/20 • Number of events 2	5.0% 1/20 • Number of events 1

Additional Information

Dr. Chanyeong Heo

Seoul National University Bundang Hospital

Phone: 82317877222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place