Intrinsic Aging of SkinPhase 1NCT02391935
Study of Intradermal Injections of RCS-01 in Male and Female Subjects
A Phase 1 study testing RCS-01 in people with Intrinsic Aging of Skin and Skin Wrinkling, run by RepliCel Life Sciences, Inc. at 1 site in Germany.
Trial summary
The primary purpose of this study is to assess the safety profile of RCS-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on skin markers related to aging through evaluation of gene expression profiles. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrinsic Aging of Skin, Skin Wrinkling, Solar Degeneration of Skin
- What is being tested?
- RCS-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2015to 12 Jul 2017
- Phase
- Phase 1
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female Caucasian in good health between the age of 50 and 65 years.
- Female subjects must be post-menopausal for at least one year or surgically sterile.
- Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.
- The treatment evaluation sites are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
Who cannot join
- Any transient skin disorder or infections (e.g. pyoderma, tinea corporis, contact or irritative dermatitis, scleroderma etc.) within 20 cm of the treatment evaluation sites or the presence of tattoos near the treatment sites.
- Subjects diagnosed with psoriasis, lichen planus, vitiligo, systemic scleroderma, or lupus erythematosus.
- Any condition that, in the investigator's opinion, would impact subject's safety and/or a subject's ability to complete all study related procedures.
- History of infection with or positive serology results for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis.
- Presence/history of hypertrophic scars and/or keloids.
- Subjects diagnosed with cancer with or without chemotherapy treatment within 3 years prior enrollment.
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- Women who are pregnant or nursing.
- Current use of any medications not permitted in the study
- Ongoing or recent participation in a cosmetic and/or clinical research study prior to enrolment.
- Subject not agreeing to avoid UV exposure (sun, solarium) on the nude buttocks during the study period.
- Known allergy or hypersensitivity to human serum albumin, DMSO, gentamicin, material of bovine origin and/or local anesthetics.
- Close affiliation with the investigational site (e.g., a close relative of the investigator or a possibly dependent person (e.g., employee or student of the investigational site)).
- Subjects diagnosed with coagulopathies or significant thrombocytopenia
Trial locations and contacts
1 site in 1 country.
Germany1 site
IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
Düsseldorf, 40225
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Single-centre, Phase I Safety Study of Intradermal Injections of RCS-01 in Male and Female Subjects (50 to 65 Years Old)
The primary purpose of this study is to assess the safety profile of RCS-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on skin markers related to aging through evaluation of gene expression profiles.
30 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. At the first visit and after providing informed consent, participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCS-01 will be prepared and will have four treatment evaluation sites identified on their buttocks, two on each side.
Read more
Study participants will be randomized to one of two treatment subgroups. Participants in the RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n= 6) will be randomized to receive only injections of placebo or sham injections.
Baseline evaluations of subjects' overall health and skin condition at treatment sites on their buttocks will be performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites will receive intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3) injections per treatment site.
All participants will return to the clinic for at least 9 visits during the 52-week follow-up period to monitor long-term safety. At the 12-week time point, 18 randomly-selected participants from the RCS-01 Subgroup will provide biopsies from all injection sites for analysis of skin markers related to aging. At the 26-week time point, the remaining participants will provide biopsies of all injection sites for histopathological analysis.
- Being tested
- RCS-01, Placebo, Sham injection
- Keywords
- Chronic Effect of Ultraviolet Radiation on Normal Skin (Photo-aging)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCS-01Drug
Cultured, autologous hair follicle cells suspended in cryomedium
PlaceboDrug
Cryomedium
Sham injectionDevice
skin penetration of the needle without injection of liquid
| Study group | Role | What they receive |
|---|---|---|
| RCS-01 | Experimental | Cultured, autologous hair follicle cells suspended in cryomedium Receives: Drug: RCS-01; Drug: Placebo; Device: Sham injection |
| Placebo | Placebo comparator | cryomedium Receives: Drug: Placebo; Device: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local adverse events
Within-patient comparison of the local (reported at treatment evaluation sites) adverse event profile between treatment evaluation sites treated with RCS-01 or placebo. The local adverse event profile is defined by the incidence, relationship to treatment, severity and seriousness of adverse events reported at the treatment evaluation sites.
Measured: 52 weeks after first injection
Secondary outcomes (3)
Incidence of adverse events
Between-subject comparison of the systemic (not reported at treatment evaluation sites) adverse event profile between participants in the RCS-01 Subgroup versus Placebo Subgroup.
Measured: 52 weeks after first injection
Incidence of abnormalities in skin structure
A within-patient and between patient comparison of histology results from analyses performed on biopsies obtained from treatment evaluation sites.
Measured: 52 weeks after first injection
Incidence of changes in markers related to skin aging
Markers to be assessed include fibrillar collagen type I (COL 1A1, COL 1A2) and type III (COL 3A1), transforming growth factor beta1, connective tissue growth factor, matrix metalloproteinases 1, 3 and 9, tissue inhibitor of matrix metalloproteinase 1 and lumican . Incidence of changes within- and between-participants.
Measured: 12 weeks after first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start10 Oct 2015
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrinsic Aging of SkinStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- RepliCel Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JensonR+ Limited, PHARMALOG Institut für klinische Forschung GmbH, Syreon Corporation, Innovacell Biotechnologie AG, Datinf GmbH
- Responsible party
- Sponsor
- Investigators
- Alessandra Marini, MD, Principal investigator, IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391935
- Sponsor's protocol ID
- RCS-01-001-2014
- Status last verified
- Oct 2017
- First submitted
- 12 Mar 2015
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Single-centre, Phase I Safety Study of Intradermal Injections of RCS-01 in Male and Female Subjects (50 to 65 Years Old)
- ClinicalTrials.gov ID
- NCT02391935
- Acronym / sponsor ID
- RCS-01-001-2014
- Keywords
- Chronic Effect of Ultraviolet Radiation on Normal Skin (Photo-aging)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- RepliCel Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- JensonR+ Limited, PHARMALOG Institut für klinische Forschung GmbH, Syreon Corporation, Innovacell Biotechnologie AG, Datinf GmbH
- Study start
- 10 Oct 2015 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 18 Mar 2015 (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 primary purpose of this study is to assess the safety profile of RCS-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on skin markers related to aging through evaluation of gene expression profiles.
30 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. At the first visit and after providing informed consent, participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCS-01 will be prepared and will have four treatment evaluation sites identified on their buttocks, two on each side.
Study participants will be randomized to one of two treatment subgroups. Participants in the RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n= 6) will be randomized to receive only injections of placebo or sham injections.
Baseline evaluations of subjects' overall health and skin condition at treatment sites on their buttocks will be performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites will receive intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3) injections per treatment site.
All participants will return to the clinic for at least 9 visits during the 52-week follow-up period to monitor long-term safety. At the 12-week time point, 18 randomly-selected participants from the RCS-01 Subgroup will provide biopsies from all injection sites for analysis of skin markers related to aging. At the 26-week time point, the remaining participants will provide biopsies of all injection sites for histopathological analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCS-01 | Experimental | Drug: RCS-01, Drug: Placebo, Device: Sham injectionCultured, autologous hair follicle cells suspended in cryomedium |
| Placebo | Placebo comparator | Drug: Placebo, Device: Sham injectioncryomedium |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female Caucasian in good health between the age of 50 and 65 years.
- Female subjects must be post-menopausal for at least one year or surgically sterile.
- Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.
- The treatment evaluation sites are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
Key exclusion criteria (13 listed)
- Any transient skin disorder or infections (e.g. pyoderma, tinea corporis, contact or irritative dermatitis, scleroderma etc.) within 20 cm of the treatment evaluation sites or the presence of tattoos near the treatment sites.
- Subjects diagnosed with psoriasis, lichen planus, vitiligo, systemic scleroderma, or lupus erythematosus.
- Any condition that, in the investigator's opinion, would impact subject's safety and/or a subject's ability to complete all study related procedures.
- History of infection with or positive serology results for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis.
- Presence/history of hypertrophic scars and/or keloids.
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 |
|---|---|---|
| RCS-01Cultured, autologous hair follicle cells suspended in cryomedium | Drug | RCS-01 |
| PlaceboCryomedium | Drug | Placebo, RCS-01 |
| Sham injectionskin penetration of the needle without injection of liquid | Device | Placebo, RCS-01 |
Primary outcome
Incidence of local adverse events
Time frame: 52 weeks after first injection
Within-patient comparison of the local (reported at treatment evaluation sites) adverse event profile between treatment evaluation sites treated with RCS-01 or placebo. The local adverse event profile is defined by the incidence, relationship to treatment, severity and seriousness of adverse events reported at the treatment evaluation sites.
3 secondary outcomes
Incidence of adverse events
Time frame: 52 weeks after first injection
Incidence of abnormalities in skin structure
Time frame: 52 weeks after first injection
Incidence of changes in markers related to skin aging
Time frame: 12 weeks after first injection
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 11 Oct 2017.
- RepliCel Life Sciences, Inc. WebsiteLink provided by the sponsor.
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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.
Alessandra Marini, MD principal investigator
IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RCS-01 in people with Intrinsic Aging of Skin and Skin Wrinkling, run by RepliCel Life Sciences, Inc. at 1 site in Germany.
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 13 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 11 Oct 2017. 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 Germany. 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 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.
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?
Incidence of local adverse events (time frame: 52 weeks after first injection). 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 11 Oct 2017.