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Tests treatment safety and results for Acneiform Eruption Due to Chemical
Official title 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
ClinicalTrials.gov ID: NCT05639933
What this study is testing
What is HT-001 2% Topical Gel?
HT-001 2% Topical Gel is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for acneiform eruption due to chemical.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult participant (ie, ≥ 18 years of age at Screening/Baseline [V1]) prescribed an approved EGFRI to treat cancer (indication within the approved...
- Approved EGFRIs include, but are not limited to: gefitinib, erlotinib, osimertinib, lapatinib, afatinib, dacomitinib, neratinib, vandetanib...
- 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...
- Participant has developed a rash or symptoms of a rash (papular and/or pustular eruptions or cutaneous burning), as assessed by both Common...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
You likely can't join if
- Participant has severe cutaneous toxicity (severity = 4 on the CTCAE grading and ARIGA scales) or cutaneous toxicity involvement that is \> 30% BSA...
- Participant has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the...
- Participant has a history of other skin disorders (eg, atopic dermatitis, psoriasis, recurrent skin infections), or history of illness that, in the...
- Participant has abnormal laboratory values at Screening/Baseline (V1):
- Absolute neutrophil count \< 1000/mm3 and WBC count \< 3000/mm3
- Platelet count \< 50,000/mm3
See the full eligibility criteria
- 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...
- Approved EGFRIs include, but are not limited to: gefitinib, erlotinib, osimertinib, lapatinib, afatinib, dacomitinib, neratinib, vandetanib, lazertinib, cetuximab, panitumumab, necitumumab, pertuzumab, and...
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Predicted life expectancy ≥ 3 months.
- 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.
- 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...
- 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...
- 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...
- Participant has abnormal laboratory values at Screening/Baseline (V1):
- Absolute neutrophil count \< 1000/mm3 and WBC count \< 3000/mm3
- Platelet count \< 50,000/mm3
- 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...
- 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...
- 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...
- 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...
- 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...
- Participant has received concomitant treatment with pimozide, moderate to strong cytochrome p450 (CYP) 3A4 inhibitors (diltiazem, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Orange, California, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Mineola, New York, United States
- New Hyde Park, New York, United States
- The Bronx, New York, United States
- Canton, Ohio, United States
- Houston, Texas, United States
- Krakow, Poland
- Lublin, Poland
- Manresa, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Orange, California, United States; Miami, Florida, United States; Boston, Massachusetts, United States; Mineola, New York, United States; New Hyde Park, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.