AgingEarly Phase 1NCT07888595
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
A Early Phase 1 study testing Topical anti-aging peptide serum in people with Aging, run by Frontiers in Bioscience Research Institute and Aging at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Topical anti-aging peptide serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2026to 14 Oct 2028
- Phase
- Early Phase 1
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 50 years or older
- Healthy, free of chronic or age-related disease
- Not taking medication for any disease
- Willing to provide blood, skin (biopsy or exfoliated cells), plucked hair, and/or saliva samples at scheduled timepoints
- Able to understand and provide written informed consent
Who cannot join
- Age under 50 years
- Pregnancy or breastfeeding
- Unable to provide informed consent
- Bedridden, comatose, or not coherent
- Any chronic, acute, or age-related disease
- Current use of any medication for a disease, including any agent with a clinically significant interaction with a study agent
Show all 12Show fewer
- Known hypersensitivity, allergy, or prior reaction/side effect to any study agent (metformin, chloroquine, ivermectin, supplement components, or topical peptides)
- Active malignancy or systemic immunosuppression
- Significant renal, hepatic, cardiac, or retinal disease
- Smokers
- Alcohol use disorder
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Frontiers in Bioscience Research Institute in Aging and Cancer
Irvine, California, 92618
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Aging
- Being tested
- Topical anti-aging peptide serum
- Keywords
- Aging, Biological aging clock, Transcriptomic aging clock, START/REST clock, Geroprotection, Rejuvenation, Cellular senescence, Skin aging, Longevity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anti-aging peptide serumDrug
Also called Ivermectin, Metformin, Hydroxychloroquine, Collagen lysate
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.
| Study group | Role | What they receive |
|---|---|---|
| Geroprotective treatment | Experimental | 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. Receives: Drug: Topical anti-aging peptide serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (11)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 4 weeks
Lactic acid by enzymatic assay, mmol/L
Change from baseline in lactic acid, measured by enzymatic assay and reported in mmol/L.
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion14 Oct 2028 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontiers in Bioscience Research Institute and Aging
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siamak Tabibzadeh, MD, Principal investigator, Frontiers in Bioscience Research Institute and Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888595
- Sponsor's protocol ID
- FBS-PRS-2026
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Lee C, Zeng J, Drew BG, Sallam T, Martin-Montalvo A, Wan J, Kim SJ, Mehta H, Hevener AL, de Cabo R, Cohen P. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015 Mar 3;21(3):443-54. doi: 10.1016/j.cmet.2015.02.009.
PubMed 25738459Baar MP, Brandt RMC, Putavet DA, Klein JDD, Derks KWJ, Bourgeois BRM, Stryeck S, Rijksen Y, van Willigenburg H, Feijtel DA, van der Pluijm I, Essers J, van Cappellen WA, van IJcken WF, Houtsmuller AB, Pothof J, de Bruin RWF, Madl T, Hoeijmakers JHJ, Campisi J, de Keizer PLJ. Targeted Apoptosis of Senescent Cells Restores Tissue Homeostasis in Response to Chemotoxicity and Aging. Cell. 2017 Mar 23;169(1):132-147.e16. doi: 10.1016/j.cell.2017.02.031.
PubMed 28340339Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003 Jun;135(6):590-2. doi: 10.1023/a:1025493705728.
PubMed 12937682Pickart L, Margolina A. Regenerative and Protective Actions of the GHK-Cu Peptide in the Light of the New Gene Data. Int J Mol Sci. 2018 Jul 7;19(7):1987. doi: 10.3390/ijms19071987.
PubMed 29986520Bos JD, Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol. 2000 Jun;9(3):165-9. doi: 10.1034/j.1600-0625.2000.009003165.x.
PubMed 10839713