NCT05639933 (CLEER) is a Phase 2 clinical trial of HT-001 2% Topical Gel in Acneiform Eruption Due to Chemical, sponsored by Hoth Therapeutics, Inc..

Who is sponsoring NCT05639933?

NCT05639933 is sponsored by Hoth Therapeutics, Inc..

What drugs are being tested in NCT05639933?

Interventions in NCT05639933: HT-001 2% Topical Gel, HT-001 1% Topical Gel, HT-001 0.5% Topical Gel, HT-001 Placebo.

What condition does NCT05639933 study?

NCT05639933 studies Acneiform Eruption Due to Chemical, Xerosis Cutis, Paronychia.

Is NCT05639933 still recruiting?

NCT05639933 is currently recruiting now. Last updated 31 March 2026.

Last reviewed 2026-03-31 · How we verify

NCT05639933: CLEER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 31 March 2026

What this trial tests

Phase 2 trial testing HT-001 2% Topical Gel in Acneiform Eruption Due to Chemical in 152 participants. Currently enrolling.

Timeline

19 July 2023

Primary endpoint
30 December 2026

30 December 2026

Quick facts

Lead sponsor	Hoth Therapeutics, Inc.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	152
Start date	19 July 2023
Primary completion	30 December 2026
Estimated completion	30 December 2026
Sites	12 locations across Spain, United States, Poland

Drugs / interventions tested

HT-001 2% Topical Gel — full drug profile →
HT-001 1% Topical Gel — full drug profile →
HT-001 0.5% Topical Gel — full drug profile →
HT-001 Placebo — full drug profile →

Conditions studied

Acneiform Eruption Due to Chemical — all drugs for Acneiform Eruption Due to Chemical →
Xerosis Cutis — all drugs for Xerosis Cutis →
Paronychia — all drugs for Paronychia →

Sponsor

Hoth Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Acneiform Eruption Due to Chemical or Xerosis Cutis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Hoth Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04544943 — Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subje · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05639933 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoth Therapeutics, Inc.
Last refreshed: 31 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05639933.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing