Trial Outcomes & Findings for Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation (NCT NCT00792688)
NCT ID: NCT00792688
Last Updated: 2021-10-28
Results Overview
Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Over the course of 1 month following the initial treatment.
Results posted on
2021-10-28
Participant Flow
Recruitment started in October 2008 and ended in 2009 at a single site, Clinical Testing Center of Beverly Hills, Beverly Hills, California, United States, 90210.
All subjects needed to meet specific inclusion and exclusion criteria as described in the Eligibility Criteria section. Eligible subjects were randomly assigned to receive GLYC-101 0.1%, GLYC-101 1%, or placebo.
Participant milestones
| Measure |
GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
Baseline characteristics by cohort
| Measure |
GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid
n=9 Participants
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid
n=8 Participants
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
n=9 Participants
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
Total
n=26 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 12.83 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 10.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Over the course of 1 month following the initial treatment.Population: Analysis was Per Protocol.
Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.
Outcome measures
| Measure |
All Treatments GLYC-101 Gel, 0.1%
n=18 Participants
|
All Treatments GLYC-101 Gel, 1.0%
n=17 Participants
|
All Treatments Placebo
n=17 Participants
|
|---|---|---|---|
|
Time to Complete Wound Closure (Epithelialization)
|
10.9 days
Standard Deviation 5.17
|
13.1 days
Standard Deviation 8.31
|
16.3 days
Standard Deviation 9.93
|
SECONDARY outcome
Timeframe: At 1 month following the initial treatment.The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).
Outcome measures
| Measure |
All Treatments GLYC-101 Gel, 0.1%
n=18 Participants
|
All Treatments GLYC-101 Gel, 1.0%
n=17 Participants
|
All Treatments Placebo
n=17 Participants
|
|---|---|---|---|
|
Cosmesis/11-point Likert Scale
|
8.9 scores on a scale
Standard Deviation 1.28
|
8.6 scores on a scale
Standard Deviation 1.17
|
8.5 scores on a scale
Standard Deviation 1.50
|
Adverse Events
GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid
n=9 participants at risk
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid
n=8 participants at risk
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
n=9 participants at risk
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
|---|---|---|---|
|
Investigations
HIV test positive
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/8 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
Other adverse events
| Measure |
GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid
n=9 participants at risk
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid
n=8 participants at risk
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other
n=9 participants at risk
GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.
|
|---|---|---|---|
|
General disorders
Application site pain
|
100.0%
9/9 • Number of events 70 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
100.0%
8/8 • Number of events 62 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
100.0%
9/9 • Number of events 71 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
General disorders
Impaired healing
|
22.2%
2/9 • Number of events 4 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
11.1%
1/9 • Number of events 2 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
66.7%
6/9 • Number of events 11 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
62.5%
5/8 • Number of events 14 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
66.7%
6/9 • Number of events 13 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Eye disorders
Eye pruritus
|
44.4%
4/9 • Number of events 11 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
37.5%
3/8 • Number of events 7 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
66.7%
6/9 • Number of events 10 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
12.5%
1/8 • Number of events 2 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/8 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
0.00%
0/8 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month.
AEs were collected at baseline and each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to 90 days. The sponsor can require changes to the communication to remove any confidential information.
- Publication restrictions are in place
Restriction type: OTHER