Human study PLS-00143

Recombinant human thymosin beta-4 (rhTβ4) improved scalp condition and microbiome homeostasis in seborrheic dermatitis.

Nonrandomized controlled study · Not reported participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

Recombinant human thymosin beta-4 (rhTβ4) improved scalp condition and microbiome homeostasis in seborrheic dermatitis.primary · Microbial biotechnology · 2021-07-28 · PMID 34318587 · DOI

Design and participants

Design: Nonrandomized controlled study
Population: Patients with scalp seborrheic dermatitis, plus healthy individuals as a reference group for microbiome comparison
Conditions: Seborrheic dermatitis of the scalp
Planned enrollment (registry): Not reported
Enrolled: Not reported
Randomized: Not reported
Completed follow-up: Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

rhTβ4 gel (intervention) · thymosin-beta-4 · Recombinant human thymosin beta-4 gel applied to the scalp · topical (scalp) · 4 weeks · Not reported assigned
Ketoconazole lotion (comparator) · Ketoconazole lotion · active · topical (scalp) · 4 weeks · Not reported assigned
Healthy controls (comparator) · Healthy individuals without seborrheic dermatitis, no treatment stated · no treatment · 21 assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Adherent Scalp Flaking Score

unclear outcome · patient-important · 4 weeks of treatment and follow-up (sustained effect) · Clinical assessment of adherent scalp flaking

rhTβ4 gel vs Ketoconazole lotion: narrative — rhTβ4 reported to give significantly greater clinical efficacy than ketoconazole, with a sustained effect

Maximum Erythema Area

unclear outcome · patient-important · 4 weeks of treatment · Clinical assessment of maximum scalp erythema area

rhTβ4 gel vs Ketoconazole lotion: narrative — Included in the clinical assessment on which rhTβ4 was reported as significantly more effective than ketoconazole

Scalp physiological conditions (transepidermal water loss, hydration, sebum secretion)

unclear outcome · surrogate · 4 weeks of treatment · Instrumental skin physiology measurements

rhTβ4 gel vs Ketoconazole lotion: narrative — rhTβ4 reported to ameliorate physiological conditions more effectively and durably than ketoconazole

Scalp microbiome composition and diversity

unclear outcome · surrogate · Baseline and after 4 weeks of treatment · Fungal and bacterial abundance and diversity of scalp microbiota

rhTβ4 gel vs Ketoconazole lotion: narrative — rhTβ4 reported to improve microbiome homeostasis and shift scalp microflora towards a healthy composition

Adverse events

None reported. That is not evidence of safety.

Monitoring: Not reported in the abstract

The authors concluded (paraphrased): The authors concluded that seborrheic dermatitis involves scalp microbial dysbiosis and that rhTβ4 gel outperformed ketoconazole on symptoms, skin physiology and microbiome balance, making it a promising therapy for preventing and treating the condition.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

abstract only: Only the abstract is available in the record; methods, numeric results and safety data are not given.
inadequate randomization: The abstract does not state that patients were randomized between rhTβ4 and ketoconazole, so group comparability is unknown.
inadequate blinding: There is no information on blinding of patients or assessors for clinician-rated flaking and erythema scores.
selective reporting: Results are given only as narrative significance claims, without effect sizes, group sizes or p-values.
short follow up: Treatment lasted 4 weeks; the length of follow-up for the claimed sustained effect is not reported.
other: No adverse event or tolerability data are reported in the abstract, despite safety being mentioned as desirable.
selection bias: The abstract does not say how patients were allocated to rhTβ4 or ketoconazole, so randomization cannot be assumed.
inappropriate endpoint: Several outcomes (transepidermal water loss, hydration, sebum, microbiome) are surrogates.

Adherent Scalp Flaking Score: No information (ROBINS-I)

Risk of bias in one result of a nonrandomized study that compares groups.

Domain judgments
Confounding	No information	The abstract does not describe how patients were allocated to rhTβ4 or ketoconazole, or whether baseline characteristics were balanced.
Selection of participants	No information	Recruitment and eligibility criteria for the 71 patients are not described in the abstract.
Classification of interventions	No information	How intervention status was defined and recorded is not reported beyond the gel or lotion assignment.
Deviations from intended interventions	No information	Adherence to the 4-week topical regimens and any co-interventions are not reported.
Missing outcome data	No information	Numbers completing and analyzed in each arm are not stated in the abstract.
Measurement of the outcome	No information	Flaking is a clinician-rated score and assessor blinding is not reported in the abstract.
Selection of the reported result	No information	No numeric results are in the abstract, so selective reporting cannot be assessed.

Allocation method, blinding and attrition are unreported; there is only abstract-level narrative reporting for a subjective score against an active comparator.

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · ROBINS-I (2016) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Maximum Erythema Area: No information (ROBINS-I)

Risk of bias in one result of a nonrandomized study that compares groups.

Domain judgments
Confounding	No information	The abstract does not describe allocation between treatment groups or adjustment for baseline differences.
Selection of participants	No information	Patient selection procedures are not described in the abstract.
Classification of interventions	No information	Intervention classification details are not reported beyond the treatment names.
Deviations from intended interventions	No information	Adherence and co-treatment information are absent from the abstract.
Missing outcome data	No information	Attrition and the analyzed numbers per arm are not reported.
Measurement of the outcome	No information	Erythema area is clinician-assessed and assessor blinding is not reported.
Selection of the reported result	No information	No numeric results or prespecification details are given.

The record gives no allocation, blinding or attrition information, and only a narrative result for a clinician-assessed outcome.

Scalp physiological conditions (transepidermal water loss, hydration, sebum secretion): No information (ROBINS-I)

Risk of bias in one result of a nonrandomized study that compares groups.

Domain judgments
Confounding	No information	Allocation method and baseline comparability of the groups are not reported in the abstract.
Selection of participants	No information	Eligibility and recruitment are not described in the abstract.
Classification of interventions	No information	Intervention classification details are not given beyond the gel versus lotion description.
Deviations from intended interventions	No information	Adherence and environmental controls for skin measurements are not reported.
Missing outcome data	No information	Numbers with physiological measurements at each timepoint are not stated.
Measurement of the outcome	No information	These are instrumental measures, but the measurement conditions and blinding are not described.
Selection of the reported result	No information	No numeric results are given, so selective reporting cannot be assessed.

Allocation, attrition and measurement conditions are unreported; results are narrative surrogate claims from an abstract only.

Scalp microbiome composition and diversity: No information (ROBINS-I)

Risk of bias in one result of a nonrandomized study that compares groups.

Domain judgments
Confounding	No information	The abstract does not describe allocation or control of factors affecting the microbiome, such as hair care or prior treatment.
Selection of participants	No information	Selection of patients and healthy controls is not described in the abstract.
Classification of interventions	No information	Intervention classification details are not reported beyond the treatment names.
Deviations from intended interventions	No information	Adherence and co-interventions during the 4 weeks are not reported.
Missing outcome data	No information	The number of samples analyzed per group is not stated in the abstract.
Measurement of the outcome	No information	Sequencing and analysis methods for the microbiota are not described in the abstract.
Selection of the reported result	No information	No numeric results are given.

Abstract-only narrative reporting of a surrogate microbiome outcome, with no information on allocation, sampling or attrition.

Claims this study informs

Improves dry eye signs and symptoms: not eligible (wrong population) for “Ocular discomfort and corneal staining”
Is safe for human administration: not eligible (insufficient data) for “Adverse events, serious adverse events and discontinuations”

Where each value comes from

arms: PMID 34318587, abstract (sentence 5) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 34318587, abstract (sentence 9) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 34318587, abstract (sentence 5) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 34318587, abstract (sentences 5-8) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 34318587, abstract (sentences 4 and 6) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 34318587, abstract (sentence 5) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 34318587, abstract (sentences 4-5) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 34318587, abstract (sentences 7-8) · extracted by AI (automated, not verified by a person) · abstract only

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).