An Early Phase 1 interventional study of Topical anti-aging peptide serum in Aging, sponsored by Frontiers in Bioscience Research Institute and Aging. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Frontiers in Bioscience Research Institute and Aging · Early Phase 1, Interventional, and Treatment
This study tests whether certain medicines and a skin treatment can slow down or partly reverse the body's aging process.
As people age, the activity of their genes changes in predictable ways. Researchers can now measure a person's "biological age" from these gene-activity patterns in skin and blood. This study uses that measurement to see whether treatment can lower a person's biological age compared with their own starting point.
Adults in the study take geroprotective ("age-protecting") agents by mouth or by injection. A separate skin serum containing small anti-aging peptides is applied to certain areas of skin, and those treated areas are compared with untreated areas on the same person.
Skin and blood samples are taken at set times to measure biological age and markers of cell aging before, during, and after treatment. The main goal is to find out whether treatment lowers measured biological age in skin and blood. The study also looks at whether the treatments are safe and well tolerated.
This is a prospective, single-group interventional study with two treatment components, systemic and topical. Each participant contributes paired treated and untreated samples and serves as their own internal control, reducing inter-individual variability in clock measurements.
Systemic component: participants receive geroprotective agents administered orally or subcutaneously. Candidate agents include metformin, low-dose chloroquine, ivermectin, and a defined nutritional supplement (collagen lysate; black seed oil or its active constituent thymoquinone; urolithin; and controlled pH modulation with citric, acetic, or glycolic acid), used alone or in combination per protocol.
Topical component: an aqueous serum of small, water-soluble anti-aging peptides below the \~500-Dalton stratum corneum penetration cutoff - GHK-Cu (\~404 Da), AHK-Cu (\~418 Da), Epitalon (\~390 Da), PGP/Pro-Gly-Pro (\~269 Da), and CLV/Cys-Leu-Val (\~333 Da) - is applied at approximately 1-3 mg/mL to defined skin sites. Treated sites are compared with matched untreated contralateral, adjacent, or distant sites on the same participant.
Blood, skin biopsies, exfoliated skin cells, plucked hair follicles, and saliva are used to assess treatment effect locally and systemically.
Objectives Primary: determine whether treatment produces a statistically significant reduction in START/REST-derived transcriptomic biological age in skin, hair, saliva, and peripheral blood, relative to each participant's baseline and untreated reference tissue.
Secondary: characterize changes in molecular markers of cellular senescence, inflammaging/SASP, transcriptional fitness, and metabolic cofactors; assess concordance between systemic and local rejuvenation signals; evaluate safety and tolerability of each agent across the treatment period.
Procedures and Sampling Skin biopsies, exfoliated keratinocytes, plucked follicles, saliva, and blood are collected at scheduled baseline, on-treatment, and post-treatment timepoints for transcriptomic profiling and senescence-marker analysis.
Outcome Definition Age-reversal is defined prospectively as a statistically significant decrease in clock-derived biological age in treated tissue relative to both baseline and untreated reference tissue.
Significance The study aims to provide the first transcriptional clock-anchored human evidence that combined systemic and topical geroprotection can drive coordinated rejuvenation across tissues.
This is the only study on the registry with Frontiers in Bioscience Research Institute and Aging as lead sponsor.
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Exclusion Criteria:
Participants receive systemic geroprotective agents (metformin, low-dose chloroquine, ivermectin, or a defined nutritional supplement - collagen lysate, thymoquinone/black seed oil, urolithin) alone or in combination, and/or a topical geroprotective formulation. Blood and skin samples are analyzed by molecular means and amount of SASP (IL6/IL8) will be measured in serum compared with each participant's untreated reference sites and baseline.
Drug: Topical anti-aging peptide serum
Water-soluble anti-aging peptides applied as an aqueous serum to defined skin sites, with matched untreated contralateral/adjacent sites as within-participant controls. Peptides are selected below the \~500-Dalton stratum corneum penetration cutoff (Bos \& Meinardi, 2000): GHK-Cu \~404 Da, AHK-Cu \~418 Da, Epitalon \~390 Da, PGP \~269 Da, and CLV \~333.4 Da. Applied at approximately 1-3 mg/mL to assess reduction in START/REST transcriptomic biological age, senescence marker loss and gain of cellular fitness in treated versus untreated skin.
Also known as: Ivermectin, Metformin, Hydroxychloroquine, Collagen lysate, Thymoquinone, Urolithin, Acid (local)
START/REST biological age (transcriptomic tAge and proteomic pAge), in years
Change from baseline in biological age from the START/REST clocks - transcriptomic age (tAge) by qPCR and proteomic age (pAge) by plasma protein ELISA panel - in treated tissue (skin, hair, saliva, and/or peripheral blood) versus each participant's untreated reference sites and baseline. Reported in years.
Time frame: 4 weeks
TART/REST transcriptional indices START^U/D (Psi) and REST (Omega), log10 ratio
Change from baseline in START\^U/D (Psi = log10\[START\_U/START\_D\]) and REST (Omega = log10\[REST/M.T.\]), measured by qPCR in treated tissue versus untreated reference sites and baseline. Unit: log10 ratio.
Time frame: 4 weeks
Senescence-associated gene expression, 9-gene qPCR panel, relative expression
Change from baseline in mRNA expression of CDKN2A, CDKN1A, CDKN1B, CXCR2, LTA4H, TIMP1, MMP1, RELA, and RRM2 by qPCR, reported as relative expression (2\^-ddCt), in treated tissue versus untreated reference sites and baseline
Time frame: 4 weeks
Plasma pro-inflammatory cytokines IL-6 and IL-8 by ELISA, pg/mL
Change from baseline in plasma interleukin-6 (IL-6) and interleukin-8 (IL-8), measured by ELISA and reported in pg/mL.
Time frame: 4 weeks
Intracellular metabolites (alpha-ketoglutarate, ATP, NAD+), micromolar
Change from baseline in intracellular alpha-ketoglutarate, ATP, and NAD+, measured by enzymatic/colorimetric assay and reported in micromolar (uM), in treated tissue versus untreated reference sites and baseline.
Time frame: 4 weeks
: NAD+/NADH ratio by enzymatic cycling assay
Change from baseline in the NAD+/NADH ratio, measured by enzymatic cycling assay and reported as a dimensionless ratio
Time frame: 4 weeks
NF-kB activity (phosphorylated p65) by ELISA, OD at 450 nm
Change from baseline in NF-kB activity, quantified as cytoplasmic and nuclear phosphorylated p65 by Instant One ELISA (Thermo Scientific) and reported as optical density at 450 nm.
Time frame: 4 weeks
Senescence-associated beta-galactosidase activity, nM 4-MU equivalents
Change from baseline in SA-beta-galactosidase activity, measured fluorometrically (excitation 360 nm, emission 465 nm) against a 4-methylumbelliferone (4-MU) standard and reported as nM 4-MU equivalents.
Time frame: 4 weeks
Oxidative DNA damage (8-OHdG) by ELISA, ng/mL
Change from baseline in 8-hydroxy-2'-deoxyguanosine (8-OHdG), measured by ELISA and reported in ng/mL
Time frame: 4 weeks
Reactive oxygen species and proteasome (UPS) activity, relative fluorescence units
Change from baseline in intracellular reactive oxygen species (DCFDA probe) and ubiquitin-proteasome (UPS) activity (fluorogenic substrate), each measured fluorometrically and reported in relative fluorescence units (RFU).
Time frame: 4 weeks
Lactic acid by enzymatic assay, mmol/L
Change from baseline in lactic acid, measured by enzymatic assay and reported in mmol/L.
Time frame: 4 weeks
TET enzyme activity by activity ELISA, relative activity (AU)
Change from baseline in ten-eleven translocation (TET) enzyme activity, measured by activity ELISA and reported as relative activity in arbitrary units (AU).
Time frame: 4 weeks
Plan to share: No — Individual participant data will not be shared outside the study team. As a small, single-site exploratory study, data-sharing infrastructure and governance are not in place, and the limited sample size raises participant re-identification risk. De-identified summary results will be reported in aggregate.
Start is estimated for Oct 2026; primary completion for Oct 2028, 23 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ivermectin