WoundsPhase 1/2NCT00656474
Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation
A Phase 1/2 study testing GLYC-101 gel (1.0 %) in people with Wounds, run by TR Therapeutics at 1 site in United States.
Trial summary
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds
- What is being tested?
- GLYC-101 gel (1.0 %)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for admission to the study:
- Patients giving informed consent for retro-auricular laser ablation between 25 and 55 years old.
- Retro-auricular area is free of any irritation, scars or dermatologic conditions which might interfere with the study.
- Willing and able to participate in the study and follow all study directions.
- Able to read, understand and sign the consent form.
Who cannot join
- Pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
- Systemic or cutaneous disease that may interfere with the study results.
- Presence of irritation or dermatologic skin conditions in the retro-auricular area.
- Known allergies to materials within the test formulations.
- Systemic or cutaneous therapy with medication that impacts wound healing (steroids, immune modulators, immune suppressants).
Trial locations and contacts
1 site in 1 country.
United States1 site
CLINICAL TESTING CENTER of BEVERLY HILLS
Beverly Hills, California, 90210
About this study
Official title: Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
Read the detailed description
The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).
- Conditions
- Wounds
- Being tested
- Placebo gel, GLYC-101 gel (1.0 %)
- Keywords
- burn wounds, wound healing
- Medical subject headings
- Wounds and Injuries, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelDrug
Administration of Placebo gel on Day 1, 3 and 5 post ablation.
GLYC-101 gel (1.0 %)Drug
Administration on Day 1, 3 and 5 post laser ablation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GLYC-101 Active Retro-auricular Site (1 per participant) Receives: Drug: GLYC-101 gel (1.0 %) |
| 2 Comparator | Placebo comparator | Placebo Retro-auricular Site (1 per participant)
This arm undergoes laser ablation with subsequent Placebo gel administration Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Wound Closure (Epithelialization)
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.
Measured: Over the course of 1 month following the initial treatment.
Secondary outcomes (1)
Percentage of Wound Epithelialized
The percentage of wound epithelialized was assessed at Day 15 post laser ablation.
Measured: Day 15 post laser ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- TR Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Joseph, MD, Principal investigator, CLINICAL TESTING CENTER of BEVERLY HILLS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656474
- Sponsor's protocol ID
- GLYC-101-1a
- Status last verified
- Oct 2021
- First submitted
- 7 Apr 2008
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Phase 2 Pilot Study to Investigate the Safety and Clinical Outcomes of 1.0 % Topically Applied GLYC-101, Compared to Placebo, in Healthy Subjects Undergoing Retro-auricular Carbon Dioxide Laser Skin Resurfacing.
- ClinicalTrials.gov ID
- NCT00656474
- Acronym / sponsor ID
- GLYC-101-1a
- Conditions
- Wounds
- Keywords
- burn wounds, wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TR TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Posted 25 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.
Detailed description
The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GLYC-101 gel (1.0 %)GLYC-101 Active Retro-auricular Site (1 per participant) |
| 2 Comparator | Placebo comparator | Drug: Placebo gelPlacebo Retro-auricular Site (1 per participant) This arm undergoes laser ablation with subsequent Placebo gel administration |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects meeting all of the following criteria will be considered for admission to the study:
- Patients giving informed consent for retro-auricular laser ablation between 25 and 55 years old.
- Retro-auricular area is free of any irritation, scars or dermatologic conditions which might interfere with the study.
- Willing and able to participate in the study and follow all study directions.
- Able to read, understand and sign the consent form.
Key exclusion criteria (5 listed)
- Pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
- Systemic or cutaneous disease that may interfere with the study results.
- Presence of irritation or dermatologic skin conditions in the retro-auricular area.
- Known allergies to materials within the test formulations.
- Systemic or cutaneous therapy with medication that impacts wound healing (steroids, immune modulators, immune suppressants).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo gelAdministration of Placebo gel on Day 1, 3 and 5 post ablation. | Drug | 2 Comparator |
| GLYC-101 gel (1.0 %)Administration on Day 1, 3 and 5 post laser ablation. | Drug | 1 |
Primary outcome
Time to Complete Wound Closure (Epithelialization)
Time frame: Over the course of 1 month following the initial treatment.
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.
1 secondary outcome
Percentage of Wound Epithelialized
Time frame: Day 15 post laser ablation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Joseph, MD principal investigator
CLINICAL TESTING CENTER of BEVERLY HILLS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLYC-101 gel (1.0 %) in people with Wounds, run by TR Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Wound Closure (Epithelialization) (time frame: Over the course of 1 month following the initial treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.