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A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors

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Trial Profile

A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Aug 2025

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At a glance

  • Drugs Aprepitant (Primary)
  • Indications Acneiform eruptions; Exanthema; Pruritus; Skin disorders
  • Focus First in man; Pharmacokinetics; Therapeutic Use
  • Acronyms CLEER; CLEER-001
  • Sponsors Hoth Therapeutics

Most Recent Events

  • 29 Jul 2025 According to a Hoth Therapeutics media release, the company announced its engagement with ICON Clinical Research Limited ("ICON") to expand it's Phase II Clinical Trial for cancer patients suffering from skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).Additional regulatory approval for the Phase II clinical trial is expected from potentially three EU countries in the upcoming months.
  • 16 Jul 2025 Planned End Date changed from 30 Jun 2025 to 30 Dec 2026.
  • 16 Jul 2025 Planned primary completion date changed from 30 Jun 2025 to 30 Dec 2026.

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