Last updated on November 2018

A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects with Atopic Dermatitis and Plaque Psoriasis


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatology | Atopic Dermatitis | Eczema
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

1.1 Inclusion Criteria

  1. Male or female, at least 18 years of age;
  2. AD subjects: Diagnosis of AD. The essential features of AD include pruritus and eczema. Eczema may be acute, subacute or chronic, should demonstrate typical morphology and have a chronic or relapsing history. Subjects must have AD lesions representing no more than 25% of total body surface area;
  3. Part 1a: AD subjects: Minimal "target lesion" severity scores of ≥1 for ≥2 of the 4 parameters of erythema, induration, excoriation and lichenification (based on components of the EASI scoring system);
  4. Part 1b and Phase 2: AD subjects: ISGA for AD score > 2 (greater than or equal to 2).
  5. PS subjects: Diagnosis of mild-moderate chronic plaque-type psoriasis. Subjects must have PS lesions representing no more than 25% of total body surface area;
  6. Part 1a: PS subjects: Minimal "target lesion" severity scores for PS of ≥1 for ≥2 of the 3 parameters of erythema, induration and desquamation (based on the components of the PASI scoring system);
  7. Part 1b and Phase 2: PS subjects: ISGA for PS score > 2 (greater than or equal to 2).
  8.  Lesions must be present in treatable areas per this protocol which include: the head [excluding scalp and eyes], neck, trunk, limbs [excluding treatment to the axillae, genitals, groin area, backs of hands, palms, and soles].
  9. Candidate for topical treatment of AD or PS;
  10. Females of child-bearing potential must have a negative urine pregnancy test within 48 hours prior to the first drug administration;
  11. Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the investigator (for example, oral contraceptive pills plus a barrier method) through the trial and for 1 month thereafter to be eligible for, and continue participation in, the study;
  12. Ability to complete the study in compliance with the protocol, including agreement in writing to apply creams only to the assigned areas; and
  13. Ability to understand and provide written informed consent

1.2 Exclusion Criteria

  1. Patients with lesions representing more than 25% of total body surface area will not be included in the study.
  2. Systemic pharmacotherapy or phototherapy for the treatment of AD or PS is indicated or required;
  3. Erythrodermic, guttate, or generalized pustular psoriasis; subjects with palmar or plantar psoriasis are allowed as long as there are other target lesions; palmar and plantar lesions, contact dermatitis, and arthropod bites cannot be used as target lesions;
  4. Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents (e.g., methotrexate, cyclosporine) within 4 weeks of the Baseline visit or anticipated need for any of these therapies during the study period;
  5. Treatment with high potency topical corticosteroids (Class I-III), Vitamin D analogs, keratolytics, coal tar (other than on the scalp, palms, groin, and/or soles), phototherapy, calcineurin inhibitors, antihistamines or any other therapeutic agents besides bland emollients within 2 weeks of the Baseline visit or anticipated need for any of these therapies during the study period;
  6. Ultraviolet (UV) or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
  7. Treatment with a biological agent (such as a monoclonal antibody) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline Visit or anticipated need for any of these therapies during the study period;
  8. AD triggered by an unavoidable environmental allergen or irritant;
  9. Contact dermatitis or drug-induced skin reactions;
  10. Concomitant skin disease that could confound clinical evaluations or increase risk to the subject;
  11. Systemic or skin infection requiring antimicrobial therapy;
  12. Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;
  13. Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome;
  14. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator;
  15. Active drug or alcohol dependence;
  16. Significant acute or chronic medical, neurological, or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study;
  17. Participation in another investigational drug or vaccine trial concurrently or within 1 year prior to Screening Visit.
  18. Previous clinical trial participation for the indication being treated in this protocol. 

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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