Clinical Trials Tracker

Active recruiting trials, recent completions, and published results — 2025–2026.

1 Recruiting 2 Active 1 Completed 2 In Development
Important: Trial information is current as of March 2026 and subject to change. Verify eligibility and details directly with trial sponsors before enrolling. This page does not constitute an endorsement or recommendation to participate.

Actively Recruiting (2025–2026)

Trials currently enrolling patients:

Recruiting Sponsor: Azitra Inc. FDA Fast Track

ATR-01: Engineered S. epidermidis for Filaggrin Deficiency Ichthyosis

Phase
Phase 1/2
Condition
Filaggrin Deficiency (IV + related)
Intervention
ATR-01 — topical engineered bacterium
Expected completion
2026–2027
Mechanism of Action

First-in-class living therapeutic. Topical application of engineered commensal bacterium (S. epidermidis) expressing recombinant human filaggrin. Restores natural filaggrin production at the skin surface — addresses the root cause rather than the symptoms.

Eligibility Criteria (Anticipated)
  • Confirmed FLG mutation(s) causing ichthyosis vulgaris or related filaggrin-deficiency phenotype
  • Aged 18+ (Phase 1 likely adult-only initially)
  • Moderate-to-severe disease severity
  • No significant immunosuppression
  • Willing to apply topical therapeutic regularly
Why this trial matters

First living therapeutic for ichthyosis — a completely novel treatment class. Instead of managing symptoms, ATR-01 aims to restore the missing protein permanently at skin level.

To learn more:

Search "ATR-01" or "Azitra" on ClinicalTrials.gov, or contact Azitra Inc. directly. Expected first patient dosing: H1 2025.

Active Trials (Limited / Not Yet Enrolling)

Ongoing trials with potential future enrolment opportunities:

Active NCT04047732 FIRST Foundation

KB105: Lipid Replacement Therapy for TGM1-Related Lamellar Ichthyosis

Phase
Phase I/II
Condition
Lamellar Ichthyosis (TGM1 mutations)
Intervention
KB105 topical lipid replacement
Expected completion
2025
Mechanism of Action

Physiologic lipid-based barrier repair. Targets the fundamental pathophysiology of TGM1-related disease — defective epidermal lipid layer — by replacing missing lipids to restore barrier function and reduce scaling.

Eligibility Criteria
  • Lamellar ichthyosis (autosomal recessive congenital ichthyosis)
  • TGM1 mutations confirmed by genetic testing
  • Adults — moderate-to-severe disease severity
  • Capacity to apply topical therapy and complete assessments
Study Design & Expected Outcomes
Study size:Up to 6 adult subjects with lamellar ichthyosis (Phase I/II)
Duration:Approximately 3.5 months treatment period
Primary outcomes:Safety, tolerability, and efficacy via IGA and VIIS scoring
Design:Intra-patient comparisons; placebo-treated target areas; imaging documentation
Register / learn more:

ClinicalTrials.gov NCT04047732 · FIRST Foundation: firstskinfoundation.org (Research Studies section)

Active — Observational NCT06669949 UCSF

SPLIS Natural History Study — Sphingosine Phosphate Lyase Insufficiency Syndrome

Study type
Observational natural history
Condition
SPLIS (SGPL1 mutations) incl. ichthyosis
Intervention
None — observational only
Expected completion
2026
About this study

Rare multisystem disorder caused by SGPL1 gene mutations. SPLIS presents with ichthyosis, nephrosis, endocrine dysfunction, neuropathy, and immune abnormalities. This observational study collects natural history data to guide future therapeutic development.

Eligibility Criteria
  • Confirmed biallelic SGPL1 mutations (any variant classification)
  • At least one SPLIS feature: ichthyosis, nephrosis, endocrine defect, neuropathy, male gonadal dysgenesis, or lymphopenia
  • OR biochemical evidence of S1P lyase deficiency in skin fibroblasts
  • OR sibling of confirmed SGPL1 mutation carrier
Register / learn more:

UCSF Clinical Trials Database: clinicaltrials.ucsf.edu/trial/NCT06669949

Completed Trials with Published Results

Trials that have finished and reported outcomes:

Completed NCT01222000 French Dermatology Research Group

Polyphénon E 10% (Green Tea Extract) for Lamellar Ichthyosis

Study type
Pilot clinical trial
Condition
Lamellar Ichthyosis (ARCI)
Intervention
Topical Polyphénon E 10% (green tea extract)
Completed
2012 — results published
Key Findings
Primary outcome:Improvement in scaling and cutaneous roughness after 4 weeks of daily topical Polyphénon E 10%
Safety:Well tolerated; minor adverse effects only
Mechanism:Polyphenols (green tea) act as antioxidants and may modulate inflammatory cascades in ichthyotic skin
Clinical implication:Topical green tea extract may offer adjunctive benefit; requires larger RCT confirmation

Trials in Development — Expected 2025–2026

CRISPR Gene Therapy (TGM1 Lamellar Ichthyosis)

Preclinical success in 2026 using non-viral LNP-mRNA-CRISPR approach. Phase I/II clinical trials expected to open 2025–2026 for TGM1-related lamellar ichthyosis.

Watch: ClinicalTrials.gov and FIRST Foundation website for IND application announcements.

Biologic Therapy Trials (Risankizumab / Anti-IL-23)

Preclinical and early clinical data promising in ichthyosis vulgaris. Formal RCTs in planning stages for inflammatory ichthyosis subtypes.

Watch: Major dermatology institutions and immunology-focused research group announcements.

How to Find & Enrol in Ichthyosis Trials

1
Check ClinicalTrials.gov

Visit clinicaltrials.gov and search "ichthyosis". Filter by: Recruiting, Active, Not Yet Recruiting. Review eligibility, contacts, and study details for each result.

2
Contact FIRST Foundation

The Foundation for Ichthyosis & Related Skin Types maintains a dedicated research registry and coordinates ichthyosis-specific trials. Visit firstskinfoundation.org → Research Studies section.

3
Consult Your Dermatologist

Discuss trial options and suitability for your type and severity. Ask about genetic testing (often required for enrolment). Request a referral to a trial site if your specialist is involved.

4
Understand Informed Consent

Carefully read the Informed Consent Form. Understand risks, benefits, and your rights as a participant. Ask all your questions before signing. You can withdraw at any time without penalty.

Essential Research Resources

Trial Registries

ClinicalTrials.gov

US registry of all clinical trials. Search "ichthyosis" for current list.

FIRST Foundation (USA)

FIRST Foundation

Ichthyosis-specific research coordination and patient support.

UK Support

ISG UK

UK patient organisation with research updates and trial signposting.

Frequently Asked Questions

Many trials require a confirmed genetic diagnosis (FLG mutations, TGM1 mutations, etc.). If you haven't had genetic testing, discuss with your dermatologist. NHS genetic testing turnaround is typically 3–8 weeks depending on the test.
Trial designs vary significantly. Some allow continued standard care; others require washout periods before the study drug. Always check the eligibility criteria and full protocol, and discuss with the trial investigators before applying.
You can withdraw at any time and return to your standard care. Trials are designed to benefit participants, but individual responses vary. Withdrawing does not affect your right to continued NHS care.
Most clinical trials cover study-related costs and in some cases provide compensation for participation. Always confirm the payment and expenses policy with trial investigators before enrolling.
Completed trials publish results in peer-reviewed journals (PubMed, ClinicalTrials.gov results section). Trial sponsors notify participants. FIRST Foundation distributes major findings to the ichthyosis community via their newsletter and website.

Keep up with ichthyosis research

Read the full research database — gene discoveries, treatment evidence, and the latest science.

→ Research Database