Trial Outcomes & Findings for Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation (NCT NCT00656474)

Results Overview

Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. 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

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Over the course of 1 month following the initial treatment.

Results posted on

2021-10-28

Participant Flow

Recruitment occurred in March 2008 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 section. Eligible subjects were randomly assigned to receive GLYC-101, 1% or placebo.

Participant milestones

Participant milestones
Measure	GLYC-101 and Placebo Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GLYC-101 and Placebo Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
Overall Study Other Reason	1

Baseline Characteristics

Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLYC-101 and Placebo n=12 Participants Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.3 years STANDARD_DEVIATION 8.93 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Over the course of 1 month following the initial treatment.

Population: Analysis was Per Protocol.

Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. 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

Outcome measures
Measure	GLYC-101 Active Retro-auricular Site (1 Per Participant) n=12 Participants GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation	Placebo Retro-auricular Site (1 Per Participant) n=12 Participants Placebo gel Administration on Day 1, 3 and 5 post laser ablation
Time to Complete Wound Closure (Epithelialization)	15 days Interval 15.0 to 15.0	15 days Interval 15.0 to 15.0

SECONDARY outcome

Timeframe: Day 15 post laser ablation.

Population: Analysis was Per Protocol.

The percentage of wound epithelialized was assessed at Day 15 post laser ablation.

Outcome measures

Outcome measures
Measure	GLYC-101 Active Retro-auricular Site (1 Per Participant) n=12 Participants GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation	Placebo Retro-auricular Site (1 Per Participant) n=12 Participants Placebo gel Administration on Day 1, 3 and 5 post laser ablation
Percentage of Wound Epithelialized	100 percent	100 percent

Adverse Events

GLYC-101 and Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GLYC-101 and Placebo n=12 participants at risk Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site. GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
Ear and labyrinth disorders Ear Pruritus	25.0% 3/12 • Number of events 6 • Adverse Events (AEs) were collected over the course of 1 month. AEs were collected at baseline and each study visit.
General disorders Granuloma	8.3% 1/12 • Number of events 1 • Adverse Events (AEs) were collected over the course of 1 month. AEs were collected at baseline and each study visit.
Nervous system disorders Headache	91.7% 11/12 • Number of events 21 • Adverse Events (AEs) were collected over the course of 1 month. AEs were collected at baseline and each study visit.
Skin and subcutaneous tissue disorders Erythema	100.0% 12/12 • Number of events 24 • Adverse Events (AEs) were collected over the course of 1 month. AEs were collected at baseline and each study visit.

Additional Information

Dr. Reinhard Koenig, CEO

Glycotex

Phone: 301-670-2825

Email: [email protected]

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