CicatrixPhase 2NCT00984386
Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
A Phase 2 study testing Zesteem in people with Cicatrix and Wound-healing, run by Renovo at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate early wound healing of one application of four different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects two years post-menopausal. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Wound-healing
- What is being tested?
- Zesteem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to Apr 2005
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects aged 18-85 years, and female subjects who are at least two years postmenopausal (quantified by a serum test result of estradiol <90 pmol/L and FSH > 31 IU/L) who have given written informed consent
- Subjects with a BMI within the permitted range for their height using Quetelet's index-weight (kg)/height² (m). The permitted index is 15-55 kg/m2
- Subjects with, in the opinion of the investigator, clinically acceptable results for laboratory safety tests performed within 28 days of the first trial dose administration
Who cannot join
- Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars within 3cm of the area to be biopsied
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
- Subjects who have had surgery in the area to be biopsied within one year of the first dosing day
- Subjects with a history of a bleeding disorder
- Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
Show all 15Show fewer
- Subjects with any clinically significant medical condition or history 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 or diabetes mellitus
- Subjects with a history of hypersensitivity to any of the drugs or dressings used in this trial
- Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration
- Subjects who are taking regular, continuous, oral corticosteroid therapy
- Subjects undergoing investigations or changes in management for an existing medical condition
- Subjects with a history of drug abuse
- Subjects with a positive drugs of abuse test for cocaine, amphetamines, methamphetamines, opiates or benzodiazepines during the screening period
- Subjects who, in the opinion of the investigator, are unlikely to complete the trial for whatever reason
- Female subjects who are currently taking any form of hormone replacement therapy or contraceptive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Site, Placebo and Standard Care Controlled, Double Blind, Randomised Trial to Investigate the Efficacy of Four Doses of Zesteem in Accelerating Early Wound Healing of Punch Biopsy Skin Wounds.
The purpose of this study is to investigate early wound healing of one application of four different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects two years post-menopausal.
Read the detailed description
Each subject received a total of six, 3mm punch biopsy wounds; three wounds to the upper inner aspect of each arm. Each punch biopsy site was randomly allocated to receive one of six treatments: Zesteem (0.02μg, 0.1μg, 0.2μg and 0.4μg/100μl), Placebo (vehicle), and Standard Care (moist wound healing dressings) only.
Zesteem and Placebo were administered to marked, anaesthetised sites, by intradermal injection 10 to 30 minutes before wounding. Sites randomised to receive Standard Care only received no additional treatment before wounding. After wounding, all sites received moist wound healing dressings (Standard Care).
Three days after wounding, all biopsy sites were anaesthetised and the wounds excised using a 5mm punch biopsy, for histological analysis. The Investigator closed all excision sites using sutures and Steri-strips to achieve a cosmetically acceptable result. Subjects attended a post-trial follow-up visit (13-18 days after dosing) where their sutures were removed and final safety assessments were performed.
- Conditions
- Cicatrix, Wound-healing
- Being tested
- Zesteem, Placebo
- Keywords
- Cicatrix, Scar, Wound-healing, Zesteem, 17β-Estradiol, RN1002
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZesteemDrug
Also called 17β-Estradiol, RN1002
Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
ZesteemDrug
Also called 17β-Estradiol, RN1002
Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
ZesteemDrug
Also called 17β-Estradiol, RN1002
Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
ZesteemDrug
Also called 17β-Estradiol, RN1002
Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
PlaceboDrug
Intradermal placebo, 100μl administered once before punch biopsy
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Zesteem | Experimental | Not described Receives: Drug: Zesteem |
| Placebo | 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 assess acceleration of early wound healing in male and postmenopausal female subjects following administration of intradermal Zesteem. The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site.
Measured: Day 3
Secondary outcomes (1)
To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.
Measured: 13-18 Days
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 startMar 2005
- Primary completionApr 2005
- Study completionApr 2005
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Duncan, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984386
- Sponsor's protocol ID
- RN1002-028
- 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 and Standard Care Controlled, Double Blind, Randomised Trial to Investigate the Efficacy of Four Doses of Zesteem in Accelerating Early Wound Healing of Punch Biopsy Skin Wounds.
- ClinicalTrials.gov ID
- NCT00984386
- Acronym / sponsor ID
- RN1002-028
- Conditions
- Cicatrix, Wound-healing
- Keywords
- Cicatrix, Scar, Wound-healing, Zesteem, 17β-Estradiol, RN1002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (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 is to investigate early wound healing of one application of four different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects two years post-menopausal.
Detailed description
Each subject received a total of six, 3mm punch biopsy wounds; three wounds to the upper inner aspect of each arm. Each punch biopsy site was randomly allocated to receive one of six treatments: Zesteem (0.02μg, 0.1μg, 0.2μg and 0.4μg/100μl), Placebo (vehicle), and Standard Care (moist wound healing dressings) only.
Zesteem and Placebo were administered to marked, anaesthetised sites, by intradermal injection 10 to 30 minutes before wounding. Sites randomised to receive Standard Care only received no additional treatment before wounding. After wounding, all sites received moist wound healing dressings (Standard Care).
Three days after wounding, all biopsy sites were anaesthetised and the wounds excised using a 5mm punch biopsy, for histological analysis. The Investigator closed all excision sites using sutures and Steri-strips to achieve a cosmetically acceptable result. Subjects attended a post-trial follow-up visit (13-18 days after dosing) where their sutures were removed and final safety assessments were performed.
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 Zesteem | Experimental | Drug: Zesteem |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects aged 18-85 years, and female subjects who are at least two years postmenopausal (quantified by a serum test result of estradiol <90 pmol/L and FSH > 31 IU/L) who have given written informed consent
- Subjects with a BMI within the permitted range for their height using Quetelet's index-weight (kg)/height² (m). The permitted index is 15-55 kg/m2
- Subjects with, in the opinion of the investigator, clinically acceptable results for laboratory safety tests performed within 28 days of the first trial dose administration
Key exclusion criteria (15 listed)
- Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars within 3cm of the area to be biopsied
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
- Subjects who have had surgery in the area to be biopsied within one year of the first dosing day
- Subjects with a history of a bleeding disorder
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 |
|---|---|---|
| ZesteemAlso: 17β-Estradiol, RN1002Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy | Drug | Intradermal Zesteem |
| ZesteemAlso: 17β-Estradiol, RN1002Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy | Drug | Intradermal Zesteem |
| ZesteemAlso: 17β-Estradiol, RN1002Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy | Drug | Intradermal Zesteem |
| ZesteemAlso: 17β-Estradiol, RN1002Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy | Drug | Intradermal Zesteem |
| PlaceboIntradermal placebo, 100μl administered once before punch biopsy | Drug | Placebo |
Primary outcome
To assess acceleration of early wound healing in male and postmenopausal female subjects following administration of intradermal Zesteem. The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site.
Time frame: Day 3
1 secondary outcome
To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.
Time frame: 13-18 Days
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.
Jonathan Duncan 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 Zesteem 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 3 inclusion and 15 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 assess acceleration of early wound healing in male and postmenopausal female subjects following administration of intradermal Zesteem. The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site. (time frame: Day 3). 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; AzTrials last refreshed its copy on 8 Nov 2026.