CicatrixPhase 2NCT00984516
Investigation Into the Safety and Scar-improvement Efficacy of Intradermal Juvidex Dosed Once or Three Times
A Phase 2 study testing Juvidex in people with Cicatrix and Wound-healing, run by Renovo at 1 site in United Kingdom.
Trial summary
The purpose of this study was to investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only or three times in male and female subjects and to collect further safety and tolerability data for intradermal Juvidex in male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Wound-healing
- What is being tested?
- Juvidex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2004to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 18-45 years who gave written informed consent
- Weight between 50-150kg with a BMI within the permitted range for their height using Quetelet's index: weight (kg)/height (m)2. The permitted range was 15-55kg/m2
- Female subjects of childbearing potential who were deemed by the Investigator to be using adequate contraception at the time of screening and who agreed to continue using this form of contraception for the duration of the trial
- In the opinion of the Investigator, and on the basis of the investigations carried out within 12 weeks prior to the first study drug dose (determined by results of electrocardiogram [ECG], physical examination, medical history, haematology and biochemistry blood results) the subject was in adequate health to undertake the trial
Who cannot join
- Subjects who on direct questioning and physical examination had a history or evidence of hypertrophic or keloid scarring or had tattoos in the area to be incised
- Afro-Caribbean subjects because of their increased susceptibility to hypertrophic and keloid scarring
- Subjects who had surgery in the area to be incised within one year of the first dosing day
- Subjects with a history of a bleeding disorder
- Subjects who, on direct questioning and physical examination, had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immuno-mediated conditions and skin diseases and allergies, such as clinically significant eczema
- Subjects with a skin disorder that was chronic or currently active and which the Investigator considered would adversely affect the healing of the acute wounds or would involve the areas to be examined in this trial
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- Subjects with any clinically significant medical condition that would impair wound healing including; significant rheumatoid arthritis, chronic renal impairment significant for their age, significant hepatic impairment (LFTs >3 times upper limit of normal), congestive heart failure, current active malignancy or history of malignancy in the last 5 years, immunosuppression or chemotherapy within the last 12 months, a history of radiotherapy and diabetes mellitus
- Subjects with a history of clinically significant drug hypersensitivity to lignocaine or an allergy to surgical dressings to be used in this trial
- Subjects who were taking or had taken any investigational product or participated in a clinical trial within the three months prior to first study drug dose for this trial
- Subjects who were taking regular, continuous, oral corticosteroid therapy
- Subjects who, in the opinion of the Investigator, were not likely to complete the trial for whatever reason
- Subjects who were, or who became, pregnant or were lactating, up to and including the time of the first dose of study drug
- Subjects undergoing/awaiting investigations or change in management for an existing medical disorder
- Subjects who had evidence of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-site, Placebo-controlled, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and the Scar-improvement Efficacy of Intradermal Applications of Three Doses of Juvidex (5.64mg/100μl, 2.82mg/100μl and 11.28mg/100μl) Given Once Only or Three Times Within and Between Male and Female Subjects Aged 18-45.
The purpose of this study was to investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only or three times in male and female subjects and to collect further safety and tolerability data for intradermal Juvidex in male and female subjects.
Read the detailed description
Subjects were randomised into three dose groups of equal size. The three dose groups were 100mM (2.82mg/100μl), 200mM (5.64mg/100μl) and 400mM (11.28mg/100μl). Before wounding, three prospective wound sites 1cm long were marked on the upper, inner aspect of each arm (anterior, posterior and distal) to give three pairs of wounds. Wounds were assigned as Pair 1 (left distal and right distal), Pair 2 (left anterior and left posterior) and Pair 3 (right anterior and right posterior).
Sites were anaesthetised using 1% plain lignocaine, then prior to wounding one site from each pair, randomly assigned, received an intradermal injection of Juvidex (100μl) and the opposite site from each pair received an intradermal injection of Placebo (100μl).
Within dose groups, subjects were randomised into two subgroups of similar size. Subgroup A received one dose in wound pairs 1 and 2; and three doses in wound pair 3. Subgroup B received three doses in wound pairs 1 and 2; and one dose in wound pair 3. Incision sites randomised to receive three injections of study medication were re-dosed with 100μl per wound margin (200μl per site) 3 hours after receiving the first dose and dosed again in the same way on Day 5.
Subjects attended a follow-up visit on Day 14. Scars were assessed monthly from Month 1 to Month 12. At Month 12, the Investigator excised the distal scars from each subject for histological examination. Posttrial follow-up visits are scheduled for Months 18 and 24.
- Conditions
- Cicatrix, Wound-healing
- Being tested
- Juvidex, Placebo
- Keywords
- Cicatrix, Scar, Wound-healing, Juvidex, Mannose-6-phosphate, M6P, RN1004
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding
JuvidexDrug
Also called Mannose-6-phosphate, M6P, RN1004
Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
PlaceboDrug
Intradermal Placebo, 100μl administered once prior to wounding
PlaceboDrug
Intradermal Placebo, 100μl administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Juvidex | Experimental | Not described Receives: Drug: Juvidex |
| Placebo (vehicle) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects.
Measured: 12 months
Secondary outcomes (2)
To collect further safety and tolerability data for various doses and dosing frequencies of intradermal Juvidex in male and female subjects.
Measured: 1 hour to 24 months
To assess systemic exposure to Juvidex, following various doses and dosing frequencies of intradermal Juvidex, before and after making minor skin incisions in male and female subjects.
Measured: 1 hour to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startAug 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Bush, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984516
- Sponsor's protocol ID
- RN1004-319-1002
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Placebo-controlled, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and the Scar-improvement Efficacy of Intradermal Applications of Three Doses of Juvidex (5.64mg/100μl, 2.82mg/100μl and 11.28mg/100μl) Given Once Only or Three Times Within and Between Male and Female Subjects Aged 18-45.
- ClinicalTrials.gov ID
- NCT00984516
- Acronym / sponsor ID
- RN1004-319-1002
- Conditions
- Cicatrix, Wound-healing
- Keywords
- Cicatrix, Scar, Wound-healing, Juvidex, Mannose-6-phosphate, M6P, RN1004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only or three times in male and female subjects and to collect further safety and tolerability data for intradermal Juvidex in male and female subjects.
Detailed description
Subjects were randomised into three dose groups of equal size. The three dose groups were 100mM (2.82mg/100μl), 200mM (5.64mg/100μl) and 400mM (11.28mg/100μl). Before wounding, three prospective wound sites 1cm long were marked on the upper, inner aspect of each arm (anterior, posterior and distal) to give three pairs of wounds. Wounds were assigned as Pair 1 (left distal and right distal), Pair 2 (left anterior and left posterior) and Pair 3 (right anterior and right posterior).
Sites were anaesthetised using 1% plain lignocaine, then prior to wounding one site from each pair, randomly assigned, received an intradermal injection of Juvidex (100μl) and the opposite site from each pair received an intradermal injection of Placebo (100μl).
Within dose groups, subjects were randomised into two subgroups of similar size. Subgroup A received one dose in wound pairs 1 and 2; and three doses in wound pair 3. Subgroup B received three doses in wound pairs 1 and 2; and one dose in wound pair 3. Incision sites randomised to receive three injections of study medication were re-dosed with 100μl per wound margin (200μl per site) 3 hours after receiving the first dose and dosed again in the same way on Day 5.
Subjects attended a follow-up visit on Day 14. Scars were assessed monthly from Month 1 to Month 12. At Month 12, the Investigator excised the distal scars from each subject for histological examination. Posttrial follow-up visits are scheduled for Months 18 and 24.
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 |
|---|---|---|
| Intradermal Juvidex | Experimental | Drug: Juvidex |
| Placebo (vehicle) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged 18-45 years who gave written informed consent
- Weight between 50-150kg with a BMI within the permitted range for their height using Quetelet's index: weight (kg)/height (m)2. The permitted range was 15-55kg/m2
- Female subjects of childbearing potential who were deemed by the Investigator to be using adequate contraception at the time of screening and who agreed to continue using this form of contraception for the duration of the trial
- In the opinion of the Investigator, and on the basis of the investigations carried out within 12 weeks prior to the first study drug dose (determined by results of electrocardiogram [ECG], physical examination, medical history, haematology and biochemistry blood results) the subject was in adequate health to undertake the trial
Key exclusion criteria (14 listed)
- Subjects who on direct questioning and physical examination had a history or evidence of hypertrophic or keloid scarring or had tattoos in the area to be incised
- Afro-Caribbean subjects because of their increased susceptibility to hypertrophic and keloid scarring
- Subjects who had surgery in the area to be incised within one year of the first dosing day
- Subjects with a history of a bleeding disorder
- Subjects who, on direct questioning and physical examination, had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immuno-mediated conditions and skin diseases and allergies, such as clinically significant eczema
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 |
|---|---|---|
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl) | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl) | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding | Drug | Intradermal Juvidex |
| JuvidexAlso: Mannose-6-phosphate, M6P, RN1004Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl) | Drug | Intradermal Juvidex |
| PlaceboIntradermal Placebo, 100μl administered once prior to wounding | Drug | Placebo (vehicle) |
| PlaceboIntradermal Placebo, 100μl administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl) | Drug | Placebo (vehicle) |
Primary outcome
To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects.
Time frame: 12 months
2 secondary outcomes
To collect further safety and tolerability data for various doses and dosing frequencies of intradermal Juvidex in male and female subjects.
Time frame: 1 hour to 24 months
To assess systemic exposure to Juvidex, following various doses and dosing frequencies of intradermal Juvidex, before and after making minor skin incisions in male and female subjects.
Time frame: 1 hour to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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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.
James Bush principal investigator
Renovo
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 Juvidex in people with Cicatrix and Wound-healing, run by Renovo at 1 site in United Kingdom.
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 14 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 25 Sep 2009. 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 Kingdom. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects. (time frame: 12 months). 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 25 Sep 2009.