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Acneiform Eruption Due to ChemicalPhase 2CLEERNCT05639933

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

A Phase 2 study testing HT-001 2% Topical Gel, HT-001 1% Topical Gel and HT-001 0.5% Topical Gel in people with Acneiform Eruption Due to Chemical and Xerosis Cutis, run by Hoth Therapeutics, Inc. at 12 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HT-001 2% Topical Gel, HT-001 1% Topical Gel and HT-001 0.5% Topical Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
12 sitesin 3 countries
Study dates
19 Jul 2023to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participant (ie, ≥ 18 years of age at Screening/Baseline [V1]) prescribed an approved EGFRI to treat cancer (indication within the approved labeling for the EGFRI and/or on National Comprehensive Cancer Network guidelines or equivalent local standards).
  • Approved EGFRIs include, but are not limited to: gefitinib, erlotinib, osimertinib, lapatinib, afatinib, dacomitinib, neratinib, vandetanib, lazertinib, cetuximab, panitumumab, necitumumab, pertuzumab, and amivantamab-vmjw.
  • Administration of an EGFRI, in combination with other drugs, for treatment of cancer is acceptable as long as the other drug is identified in the approved label of the EGFRI (eg, erlotinib with gemcitabine) or part of the NCCN guidelines or equivalent local standards.
  • Participant has developed a rash or symptoms of a rash (papular and/or pustular eruptions or cutaneous burning), as assessed by both Common Terminology Criteria for Adverse Events (CTCAE) grading and ARIGA scales (severity ≤ 3) with overall involvement ≤ 30% BSA.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Predicted life expectancy ≥ 3 months.
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  • Participant is able and willing to comply with contraceptive requirements
  • Participant must have the ability and willingness to attend the necessary visits (telehealth and in person).
  • Participant must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Who cannot join

  • Participant has severe cutaneous toxicity (severity = 4 on the CTCAE grading and ARIGA scales) or cutaneous toxicity involvement that is > 30% BSA, or other severe systemic toxicity (severity > 3 on the CTCAE v5.0 scale) as a result of EGFRI therapy.
  • Participant has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant would comply with the protocol or complete the study per protocol.
  • Participant has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the opinion of the Investigator, would confound results of the study or pose unwarranted risk in administering study drug to the participant.
  • Participant has abnormal laboratory values at Screening/Baseline (V1):
  • Absolute neutrophil count < 1000/mm3 and WBC count < 3000/mm3
  • Platelet count < 50,000/mm3
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  • Aspartate transaminase (AST) > 2.5 × upper limit of normal (ULN)
  • Alanine transaminase (ALT) > 2.5 × ULN
  • Bilirubin > 1.5 × ULN
  • Creatinine > 1.5 × ULN
  • Participant has a known history of QT interval prolongation.
  • Participant has a prescribed cancer treatment plan that requires radiation treatment to the head, neck, or upper trunk concurrent with EGFRI therapy or has previously received radiation therapy within 4 weeks prior to Screening/Baseline (V1).
  • Participant has received aprepitant or other neurokinin-1 receptor antagonist within 4 weeks prior to Screening/Baseline (V1).
  • Participant has had prior treatment with an investigational drug within 4 weeks prior to Screening/Baseline (V1), or at least 8 half-lives of the drug, whichever is longer.
  • Participant has an active infection (eg, pneumonia or pneumonitis) or any uncontrolled disease except for the malignancy that, in the opinion of the Investigator, might confound the result or the study or pose unwarranted risk in administering the study drug to the participant.
  • Participant has received non-stable escalating doses of topical antibiotics, topical steroids, or other topical treatments within 14 days prior to Screening/Baseline (V1). Participants who have been on stable doses of topical antibiotics, topical steroids, or other topical treatments for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed.
  • Participant has used non-stable escalating doses of systemic steroids within 14 days prior to Screening/Baseline (V1) excluding low dose systemic corticosteroids as part of standard of care for prevention or treatment of chemotherapy-induced nausea and vomiting; acceptability of the steroid and dose is to be determined by the Investigator. Participants who have been on a stable dose of systemic steroids for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI related toxicities is allowed. Use of steroid inhalers and nasal corticosteroids is allowed.
  • Participant has received non-stable escalating dose treatment with a systemic antibiotic within 14 days prior to Screening/Baseline (V1). Participants who have been on stable doses of systemic antibiotics for 14 days or more are allowed to be enrolled and to stay on their current prescription. Reduction in dose due to improvement in EGFRI-related toxicities is allowed.
  • Participant has received concomitant treatment with pimozide, moderate to strong cytochrome p450 (CYP) 3A4 inhibitors (diltiazem, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir), or strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin) within 30 days of Screening/Baseline (V1).
  • Participant has a history of hypersensitivity to aprepitant or any component of HT-001.
  • Participant is pregnant or lactating at Screening/Baseline (V1) or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.

Trial locations and contacts

12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Hayley Springer contact

866-239-7459

admin@hoththerapeutics.com

12 sites in 3 countries

United States9 sites, 9 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Study Coordinator, 617-632-2987

    Connie Shi, MD

    Recruiting

  • Gabrail Cancer & Research Center

    Canton, Ohio, 44718

    Study Coordinator, 330-492-3345 ext. 227

    Nashat Gabrail, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Stacie Stutt, 713-794-1918

    Anisha Patel, MD

    Recruiting

  • UCI Health - CIACC

    Irvine, California, 92612

    Bao-An Huynh, 714-509-6233, baoanh1@hs.uci.edu

    Janellen Smith, MD

    Recruiting

  • Regis Clinical Research

    Miami, Florida, 33126

    Study Coordinator, 305-546-3952

    Yilena Rodriguez, MD

    Recruiting

  • NYU Langone Health

    Mineola, New York, 11501

    Study Coordinator, 516-639-6493

    Mario Lacouture, MD

    Recruiting

  • Northwell Physician Partners Dermatology

    New Hyde Park, New York, 11042

    Study Coordinator, 516-321-8653

    Sheila Shaigany, MD

    Recruiting

  • UC Irvine - Chao Family Cancer Center

    Orange, California, 92868

    Bao-An Huynh

    Janellen Smith, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Study Coordinator, 718-920-8352

    Beth McLellan, MD

    Recruiting

Other trials in United States

Poland2 sites

  • Centrum Medyczne Pratia Krakow

    Krakow, 30-727

    Active, not recruiting

  • NZOZ Neuromed M. i M. Nastaj Sp.P

    Lublin, 20-064

    Active, not recruiting

Other trials in Poland

Spain1 site

  • Hospital Sant Joan de Deu-Fundacio Althaia

    Manresa, 8243

    Active, not recruiting

Other trials in Spain

About this study

Official title: 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

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
Read more

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.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2a dose-ranging study to evaluate the efficacy, safety, and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity. The study will include adult patients (≥ 18 years of age) scheduled to receive initial or repeat EGFRI therapy.

The study will be conducted in 2 periods: Part 1, an open-label cohort consisting of 12 patients to measure pharmacokinetics of HT 001 gel followed by Part 2, a randomized, parallel arm study comparing 3 dose strengths of HT-001 gel to placebo (HT 001 vehicle). Patients in the randomized cohorts will be randomly assigned to 1 of the 4 treatment arms in a 2:2:2:1 ratio (active groups = 2: placebo = 1).

All patients in both open-label and blinded cohorts will apply the study drug once a day to each area affected with cutaneous toxicity up to 30% body surface area (BSA) involvement, inclusive of skin, scalp, and nails.

The goal of the study is to determine the minimum efficacious dose strength(s) for further investigation. The dose effect, together with the application site safety assessments, and therapeutic effects based on the primary and secondary endpoints will be evaluated.

Being tested
HT-001 2% Topical Gel, HT-001 1% Topical Gel, HT-001 0.5% Topical Gel, HT-001 Placebo
Keywords
Acneiform rash, EGFR inhibitor, Cutaneous toxicities
Medical subject headings
Paronychia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HT-001 2% Topical GelDrug

    Topical gel, 2% active

  • HT-001 1% Topical GelDrug

    Topical gel, 1% active

  • HT-001 0.5% Topical GelDrug

    Topical gel, 0.5% active

  • HT-001 PlaceboDrug

    Topical gel, vehicle gel

Study groups in NCT05639933
Study groupRoleWhat they receive
Open-Label PK CohortExperimentalTopical treatment with HT-001 2% Gel unblinded.
Receives: Drug: HT-001 2% Topical Gel
Randomized, Double Blind CohortPlacebo comparatorTopical treatment with HT-001 (2%, 1%, or 0.5%) or placebo (HT-001 vehicle), blinded
Receives: Drug: HT-001 2% Topical Gel; Drug: HT-001 1% Topical Gel; Drug: HT-001 0.5% Topical Gel; Drug: HT-001 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acneiform Rash Investigator's Global Assessment Scale [ARIGA ]

    Proportion of patients with a grade ≤ 1 based on the Acneiform Rash Investigator's Global Assessment [ARIGA] Scale; novel 5-point scale 0-4 with score of 0 is clear and grade 4 being most severe

    Measured: 6 weeks

  2. Pharmacokinetics of HT-001 applied topically [Cohort 1] - Area Under the Curve (AUC)

    Characterize pharmacokinetics of HT-001 parameters including: measured drug concentrations above the lower limit of quantitation, number of patients with measurable systemic exposure; if data allow - area under the curve (AUC)

    Measured: Day 1 and Day 42

  3. Pharmacokinetics of HT-001 applied topically [Cohort 1] - Peak Plasma Concentration (Cmax)

    Characterize pharmacokinetics of HT-001 parameters including: maximum (or peak) serum concentration (Cmax)

    Measured: Day 1 and Day 42

Secondary outcomes (11)

  1. Pruritus Numeric Rating Scale (NRS)

    Change from Baseline in Pruritus Numeric Rating Scale (average itch and worst itch); The numerical scale is ranked from 0 ("no itch") to 10 ("worst imaginable itch").

    Measured: 3 weeks and 6 weeks

  2. Pain Numeric Rating Scale

    Change from Baseline in pain based on a 11-point NRS (where "0" indicates "no pain", "5" indicates "moderate pain" and "10" indicates "worst pain imaginable")

    Measured: 3 weeks and 6 weeks

  3. Change in acneiform rash severity

    Change from Baseline in acneiform rash grade based on the Acneiform Rash Investigator's Global Assessment Scale [ARIGA]; novel 5-point scale 0-4 with score of 0 is clear and grade 4 being most severe

    Measured: 3 weeks and 6 weeks

  4. Time to improvement

    Time to improvement in at least one grade using the Acneiform Rash Investigator's Global Assessment Scale [ARIGA ] for acneiform rash; novel 5-point scale 0-4 with score of 0 is clear and grade 4 being most severe

    Measured: 6 weeks Day 1- Day 42

  5. Time to rescue therapy

    Time to topical rescue therapy treatment after initiation of HT-001

    Measured: Treatment Day 1- Day 42

  6. EGFR Inhibitor dose reduction or discontinuation

    Proportion of patients with EGFRI dose reduction or discontinuation during the 6-week treatment period

    Measured: Treatment Day 1- Day 42

  7. Safety and tolerability of HT-001

    Incidence of treatment-emergent adverse events and treatment-emergent serious adverse events

    Measured: screening, Day 1 - 42, follow-up (Day 56)

  8. Modified Draize Scale

    Assessment of skin irritation through measurement of cutaneous signs of erythema (score 0-3; 3 is most severe) and edema (add 0.5 if present)

    Measured: Day 1, 7, 21, 35, 42, 56

  9. Physical Examination

    full physical examination will include examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, heart, lungs, abdomen, lymph nodes, extremities, and nervous system. An AE form must be completed for all changes identified as clinically noteworthy.

    Measured: Day 1, 7, 21, 35, 42, 56

  10. Height

    Height recorded in inches

    Measured: Screening

  11. Body weight

    Body weight in pounds.

    Measured: Day 1, 21, 42, 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start19 Jul 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05639933
Sponsor's protocol ID
CLEER-001
Acronym
CLEER
Status last verified
Mar 2026
First submitted
14 Nov 2022
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guenther L, Lynde CW, Andriessen A, Barankin B, Goldstein E, Skotnicki SP, Gupta SN, Choi KL, Rosen N, Shapiro L, Sloan K. Pathway to dry skin prevention and treatment. J Cutan Med Surg. 2012 Jan-Feb;16(1):23-31. doi: 10.1177/120347541201600106.

    PubMed 22417992

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HT-001 2% Topical Gel, HT-001 1% Topical Gel and HT-001 0.5% Topical Gel in people with Acneiform Eruption Due to Chemical and Xerosis Cutis, run by Hoth Therapeutics, Inc. at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hayley Springer (866-239-7459, admin@hoththerapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acneiform Rash Investigator's Global Assessment Scale [ARIGA ] (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05639933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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