TB-500 Topical (Creams and Serums): What Studies Show
Which studies gave TB-500 as a topical form, what they measured, and what is approved. No product recommendations.
- Route
- topical
- FDA-approved product for this route
- None
- Route studies (human / animal)
- 4 / 1
- in our evidence file (PubMed search, 11 Oct 2026)
Studies that gave TB-500 topical
Each row is a study whose stated route matches. Animal and cell results are labelled and are not human results.
| Study | Design | n | Dose | First outcome |
|---|---|---|---|---|
| Microbial biotechnology 2021, PMID 34318587 | Human controlled trial | 71 | 0.5 mg/ml gel | Scalp seborrheic dermatitis: The thymosin beta-4 gel was reported more effective than ketoconazole lotion for scalp seborrheic dermatitis (randomization not stated in abstract). |
| Cornea 2015, PMID 25826322 | Human RCT | 9 | 0.1% | Ocular discomfort and corneal staining: At day 56, the treated group had a 35.1% greater reduction in ocular discomfort and a 59.1% greater reduction in total corneal fluorescein staining than vehicle (very small trial). |
| Clinical ophthalmology 2015, PMID 26056426 | Human RCT | 72 | 0.1% | Primary endpoints: Neither primary endpoint (ocular discomfort, inferior corneal staining) differed significantly between groups. |
| Annals of the New York Academy of Sciences 2010, PMID 20536470 | Human RCT | 73 | topical, 0.03% dose highlighted | Wound healing: Phase 2 findings suggest a 0.03% dose may accelerate healing, with complete healing within 3 months in about 25% of patients, mainly those with smaller or milder ulcers. |
| ACS applied materials & interfaces 2025, PMID 41359360 | Animal · human corneal cells in vitro plus an animal alkali burn model (species not stated in abstract) (not a human result) | Not stated | Not stated | Corneal alkali burn: The peptide-containing hydrogel accelerated corneal epithelial regeneration and reduced inflammation in an alkali burn model; this is a formulation study. |
For the injected form, see TB-500 how to inject and TB-500 half-life.
Gel and cream studies (full-length thymosin beta-4)
A double-blind, placebo-controlled, dose-escalation trial gave topical full-length thymosin beta-4 (not TB-500) to 73 patients with venous stasis ulcers at eight European sites.[4]
A 4-week study of 71 scalp seborrheic dermatitis patients compared a 0.5 mg/ml recombinant full-length thymosin beta-4 gel (not TB-500) with 2% ketoconazole lotion.[1]
Eye drop and hydrogel studies
Nine patients with severe dry eye received 0.1% full-length thymosin beta-4 eye drops (not TB-500) or vehicle 6 times daily over 28 days.[2]
A second dry-eye trial randomized 72 subjects 1:1 to 0.1% thymosin beta-4 solution (full-length, not TB-500) or placebo for 28 days.[3]
The only topical study naming the TB500 sequence is a hydrogel in human corneal cells and an alkali-burn animal model, with no people treated.[5]
Safety reported by route
The 72-subject dry-eye trial reported no adverse events.[3]
The venous ulcer trial judged the safety profile of all doses acceptable and comparable to placebo.[4]
Absorption compared with injection
None of the 5 topical studies cited on this page reports a blood level or bioavailability figure for the topical route, so no comparison with injection can be drawn from them.
Calculated from topical studies 5; studies reporting topical absorption 0. Formula: studies with topical absorption data = 0 of 5
Common questions
Is there an FDA-approved topical form of TB-500?
We found no FDA-approved topical product for TB-500 in our evidence file. Products sold as topical forms are not checked by the FDA.
Have studies given TB-500 as a topical form?
5 studies in our evidence file gave TB-500 by a topical route: 4 in people and 1 in animals.
Is there a TB-500 cream or topical?
No product is approved: the Drugs@FDA lookup for thymosin beta returned no matches. The topical trials used full-length thymosin beta-4.[6]
More on TB-500
Sources
- 1Recombinant human thymosin beta-4 (rhTβ4) improved scalp condition and microbiome homeostasis in seborrheic dermatitis.Microbial biotechnology · 2021PMID 34318587Accessed 2 Oct 2026
- 2Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial.Cornea · 2015PMID 25826322Accessed 2 Oct 2026
- 3Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model.Clinical ophthalmology (Auckland, N.Z.) · 2015PMID 26056426Accessed 2 Oct 2026
- 4The effect of thymosin treatment of venous ulcers.Annals of the New York Academy of Sciences · 2010PMID 20536470Accessed 2 Oct 2026
- 5Alkaline Phosphatase-Triggered Spatiotemporal Repair of Corneal Injury with TB500 Peptide Hydrogel.ACS applied materials & interfaces · 2025PMID 41359360Accessed 2 Oct 2026
- 6Drugs@FDA (openFDA) search: active ingredient "thymosin beta"U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
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