Papulopustular Rosacea Clinical Trial
Official title:
A Phase 1b/2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of ATR-04 to Reduce the Severity of Epidermal Growth Factor Inhibitor Associated Papulopustular Rash
Verified date | June 2021 |
Source | Azitra Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period). The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.
Status | Suspended |
Enrollment | 60 |
Est. completion date | January 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject must be at least 18 years of age inclusive, at the time of signing the informed consent - Subjects with a current diagnosis of cancer - IGA grade of 0 on the face - Life expectancy, in the Investigator's opinion, greater than 12 weeks - Plan to initiate treatment with one of the following EGFRI drugs (other treatments may be considered after consultation with the Sponsor): Cetuximab or Panitumumab or erlotinib - Able to use Dove sensitive skin body wash for the duration of the treatment period. - Acceptable and willing to delay start of EGFRI therapy until study eligibility is determined - Anticipated to continue EGFRI therapy for at least 28 days after the first application of study medication - Male and/or female - Contraceptive use by men or women consistent with the EGFRI treatment package insert regarding the methods of contraception for those participating in clinical studies - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol. Exclusion Criteria: - Active bacterial skin infections on the face - Inter-current illness that in the Investigator's opinion puts the subject at undue risk by study participation or interfere with the study conduct or evaluations - Pregnant women - EGFRI therapy within the previous 12 weeks - Radiation therapy exposure to the face within the previous 8 weeks - Use of topical steroids on the face within the previous 4 weeks - Use of systemic antibiotics or topical antibiotics on the face in the previous 7 days - Participation in an investigational clinical study in which administration of an investigational study medication occurred with the previous 30 days |
Country | Name | City | State |
---|---|---|---|
United States | RCTS, Inc. | Irving | Texas |
Lead Sponsor | Collaborator |
---|---|
Azitra Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Endpoint to Evaluate Change in EGFRI Skin Rash Microbiome | Evaluate the microbiome of EGFRI skin rashes as determined by shotgun sequencing. | Through study completion, on average of 1 year | |
Other | Exploratory Endpoint to Evaluate the Change in Skin Microbiome Associated with EGFRI Therapy | Evaluate the change in skin microbiome associated with EGFRI therapy as determined by shotgun sequencing. | Through study completion, on average of 1 year | |
Primary | Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs. | Safety and tolerability of ATR-04 compared to placebo as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory values, physical exams and vital signs. | Through study completion, on average of 1 year | |
Secondary | Efficacy of ATR-04 assessed by IGA. | Assess the efficacy of ATR-04 compared to placebo to mitigate the severity of EGFRI-associated skin effects as assessed by IGA. | Up to Day 29 | |
Secondary | Proportion of Subjects with Moderate or Severe Rash | Difference in proportion of subjects with moderate or severe facial rash as assessed by IGA. | Up to Day 29 | |
Secondary | Difference in Subjects That Require Additional Therapies | Difference in number of subjects that require additional therapies for the facial rash, such as antibiotics or steroids for ATR-04 compared to placebo. | Up to Day 29 | |
Secondary | Difference in Quality of Life (QoL) of Subjects | Difference in QoL of subjects on ATR-04 compared to placebo as assessed by FACT-EGFRI-18. Score ranges from 0-72, with higher scores indicating better outcomes. | Up to Day 58. | |
Secondary | Difference in Number of Inflammatory Lesions | Difference in number of inflammatory lesions on face for subjects on ATR-04 compared to placebo. | Up to Day 29. | |
Secondary | Difference in Proportion of Subjects That Stop/Decrease EGFRI Therapy | Difference in proportion of subjects that stop or decrease dose of EGFRI therapy. | Up to Day 29. |
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