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A Study of ATI-502 Topical Solution for the Treatment of Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03585296
Recruitment Status : Completed
First Posted : July 13, 2018
Results First Posted : February 6, 2020
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
This is an open label, multicenter study designed to evaluate the safety and tolerability of ATI-502 Topical Solution in male and female subjects with moderate or severe atopic dermatitis (AD). Subjects will be required to apply ATI-502 study medication to their identified AD treatment areas. All subjects will be required to complete a safety follow up visit 4 weeks post last study medication application

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ATI-502 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Safety Study of ATI-502 Topical Solution in Subjects With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : April 25, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: ATI-502
ATI-502 topical solution applied daily for four weeks.
Drug: ATI-502
Topical Solution

Primary Outcome Measures :
  1. Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 8 weeks ]
    Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or non-pregnant, non-nursing female subjects ≥ 18 years old at the time of informed consent.
  2. Subject must have diagnosis of AD.
  3. Subject must have a diagnosis of moderate or severe AD for a period of ≥6 months prior to the first dose of study medication.
  4. Body surface area involvement must be between 2-20%.
  5. Subject must have an absolute neutrophil count and a platelet count within normal range.
  6. Subject must be willing to refrain from excess of sun exposure.
  7. Subjects must refrain from participating in strenuous exercise that would cause profuse sweating for a period of 6 hours after each treatment application with ATI-502.
  8. Be in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the subject or which might expose the subject to an unacceptable risk by study participation.
  9. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication.
  10. Sexually active male subjects must agree to use a barrier method of contraception from the first application of study medication to at least 30 days after the last application of study medication.

Exclusion Criteria:

  1. Subject has any signs or symptoms associated with AD therapy which, in the investigator's opinion, might impair evaluation of the AD or which exposes the subject to unacceptable risk by study participation.
  2. Subjects unable to complete the required washout periods. Use of prescription moisturizers within 7 days of Visit 1.
  3. Subject has used any emollients/moisturizers on the planned treatment area (s) within 4 hours of Visit 1.
  4. Subject has clinically infected AD.
  5. Subject is currently using an oral H1 antihistamines (e.g. diphenhydramine, terfenadine) UNLESS the subject is on a stable dose for at least 14 days prior to Visit 1.
  6. Clinically significant laboratory abnormalities at Visit 1 that, in the opinion of the Investigator, would make the subject a poor candidate for the study.
  7. History of, or current, severe, progressive or uncontrolled renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (renal disease) or hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, as determined by the Investigator, would preclude participation in and completion of study assessments.
  8. History of, current or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease, other than subjects with: a history of adequately treated and well healed and completely cleared non-melanoma skin cancers (basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.
  9. Evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment or history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.
  10. History of a serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to Visit 2. Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to enrollment into the study.
  11. Positive serological test for HIV(antibody), HCV (antibody), or HepB (HBsAg). Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before study enrollment. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).
  12. Screening ECG findings of:

    1. QTcF >450msec for males or >470msec for females.
    2. Heart rate < 45 or > 100 beats/minutes (inclusive).
    3. Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm (ectopic atrial rhythm).
    4. Conduction disturbance including PR >240msec, pre-excitation (delta wave and PR <120msec), second degree or higher AV block.
    5. Acute or chronic signs of ischemia.
    6. Left Bundle Branch Block.
    7. Prior myocardial infarction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03585296

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United States, California
Aclaris Investigational Site
Encinitas, California, United States, 92024
Aclaris Investigator Site
San Diego, California, United States, 92123
United States, Minnesota
Aclaris Investigator Site
Fridley, Minnesota, United States, 55432
United States, Ohio
Aclaris Investigational Site
Bexley, Ohio, United States, 43209
United States, Oregon
Aclaris Investigational Site
Portland, Oregon, United States, 97223
United States, Texas
Aclaris Investigator Site
Austin, Texas, United States, 78759
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
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Study Chair: Judy Schynder, MBA Aclaris Therapeutics
  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:
Study Protocol  [PDF] August 17, 2018
Statistical Analysis Plan  [PDF] May 14, 2019

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Responsible Party: Aclaris Therapeutics, Inc. Identifier: NCT03585296    
Other Study ID Numbers: ATI-502-AD-201
First Posted: July 13, 2018    Key Record Dates
Results First Posted: February 6, 2020
Last Update Posted: February 17, 2020
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases