WoundsPhase 2NCT00792688
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
A Phase 2 study testing GLYC-101 Gel (0.1%) and GLYC-101 Gel (1.0%) in people with Wounds, run by TR Therapeutics at 1 site in United States.
Trial summary
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds
- What is being tested?
- GLYC-101 Gel (0.1%) and GLYC-101 Gel (1.0%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2010
- Phase
- Phase 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal.
- Lower eyelid skin is free of any irritation, scarring 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 prior to any study related procedures.
Who cannot join
- Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
- Presence of irritation or dermatologic skin conditions in the lower eyelid area.
- Known allergies to materials within the test formulations (i.e., yeast and/or yeast products).
- Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation.
- A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change.
- An unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications.
- Use of any investigational medication or device for any indication within 30 days of screening.
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 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.
- Conditions
- Wounds
- Being tested
- GLYC-101 Gel (0.1%), GLYC-101 Gel (1.0%), GLYC-101 Placebo
- 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.
GLYC-101 Gel (0.1%)Drug
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 Gel (1.0%)Drug
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
GLYC-101 PlaceboDrug
Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid Receives: Drug: GLYC-101 Gel (0.1%); Drug: GLYC-101 Placebo |
| 2 | Experimental | GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid Receives: Drug: GLYC-101 Gel (1.0%); Drug: GLYC-101 Placebo |
| 3 | Experimental | GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid Receives: Drug: GLYC-101 Gel (0.1%); Drug: GLYC-101 Gel (1.0%) |
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 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.
Measured: Over the course of 1 month following the initial treatment.
Secondary outcomes (1)
Cosmesis/11-point Likert Scale
The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).
Measured: At 1 month following the initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionJan 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- TR Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Joseph, MD, Principal investigator, The Clinical Testing Center of Beverly Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792688
- Sponsor's protocol ID
- GLYC-101-1b
- Status last verified
- Oct 2021
- First submitted
- 14 Nov 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 Study to Investigate the Safety and Efficacy of 0.1% and 1.0% Topically Applied GLYC-101, Compared to Placebo, in Patients Undergoing Carbon Dioxide Laser Skin Resurfacing of the Lower Eyelids.
- ClinicalTrials.gov ID
- NCT00792688
- Acronym / sponsor ID
- GLYC-101-1b
- Conditions
- Wounds
- Keywords
- burn wounds, wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- TR TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Nov 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.
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GLYC-101 Gel (0.1%), Drug: GLYC-101 PlaceboGLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid |
| 2 | Experimental | Drug: GLYC-101 Gel (1.0%), Drug: GLYC-101 PlaceboGLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid |
| 3 | Experimental | Drug: GLYC-101 Gel (0.1%), Drug: GLYC-101 Gel (1.0%)GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal.
- Lower eyelid skin is free of any irritation, scarring 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 prior to any study related procedures.
Key exclusion criteria (7 listed)
- Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
- Presence of irritation or dermatologic skin conditions in the lower eyelid area.
- Known allergies to materials within the test formulations (i.e., yeast and/or yeast products).
- Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation.
- A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change.
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 |
|---|---|---|
| GLYC-101 Gel (0.1%)Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. | Drug | 1, 3 |
| GLYC-101 Gel (1.0%)Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. | Drug | 2, 3 |
| GLYC-101 PlaceboTopical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. | Drug | 1, 2 |
Primary outcome
Time to Complete Wound Closure (Epithelialization)
Time frame: Over the course of 1 month following the initial treatment.
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.
1 secondary outcome
Cosmesis/11-point Likert Scale
Time frame: At 1 month following the initial treatment.
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
The 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 2 study testing GLYC-101 Gel (0.1%) and 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 4 inclusion and 7 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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.