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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)
Sponsor study identifier
interventional
17
1 country
1
Study Start
October 10, 2015
Actual (reported)Primary Completion
July 12, 2017
Actual (reported)Study Completion
July 12, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 12, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2015
Actual (reported)March 18, 2015
Actual (reported)October 10, 2015
Actual (reported)July 12, 2017
Actual (reported)July 12, 2017
Actual (reported)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.
52 weeks after first injection
Incidence of adverse events
52 weeks after first injection
Incidence of abnormalities in skin structure
52 weeks after first injection
Incidence of changes in markers related to skin aging
12 weeks after first injection
Cultured, autologous hair follicle cells suspended in cryomedium
cryomedium
Cultured, autologous hair follicle cells suspended in cryomedium
Cryomedium
IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
Düsseldorf, 40225, Germany
Alessandra Marini, MD
IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH
17 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2015
First Posted
March 18, 2015
Study Start
October 10, 2015
Actual (reported)skin penetration of the needle without injection of liquid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 12, 2017
Actual (reported)Study Completion
July 12, 2017
Actual (reported)Last Updated
October 11, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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