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

Conditions

• Acneiform Eruption Due to Chemical
• Paronychia
• Xerosis Cutis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HT-001 2% Topical Gel — DRUG
  Topical gel, 2% active
• HT-001 1% Topical Gel — DRUG
  Topical gel, 1% active
• HT-001 0.5% Topical Gel — DRUG
  Topical gel, 0.5% active
• HT-001 Placebo — DRUG
  Topical gel, vehicle gel

Study Details

The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities. The main questions it aims to answer are: * Determine the therapeutic effect of HT-001 for treatment of patients who develop acneiform rash undergoing Epidermal Growth Factor inhibitor (EGFRI) therapy using the acneiform rash investigator's global assessment scale \[ARIGA\] * Evaluate the safety of HT-001 during treatment Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash or other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching (pruritus), as well as the change in quality of life. The study will be completed in 2 periods: the first period is open-label (unblinded) and all patients will receive HT-001 topical gel with the active ingredient; the second period is blinded and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Researchers will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.

Key Dates

Start date

Jul 19, 2023

Status verified

Mar 2026

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

152 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Open-Label PK Cohort
  Topical treatment with HT-001 2% Gel unblinded.
• Placebo Comparator: Randomized, Double Blind Cohort
  Topical treatment with HT-001 (2%, 1%, or 0.5%) or placebo (HT-001 vehicle), blinded

Primary Outcome Measure

Acneiform Rash Investigator's Global Assessment Scale [ARIGA ] [ Time Frame: 6 weeks ]

Central Contacts

• Hayley Springer
  866-239-7459
  [email protected]

Locations (9)

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