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A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo

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ClinicalTrials.gov Identifier: NCT03468855
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution, 0.46% in subjects with non-segmental facial vitiligo.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: ATI-50002 topical solution Phase 2

Detailed Description:
This is a multicenter, open-label study designed to evaluate the safety, tolerability and efficacy of ATI-50002 Topical Solution 0.46% in subjects with non-segmental facial vitiligo. Subjects will be required to have a clinical diagnosis of non-segmental facial vitiligo effecting at least 0.25% of total body surface area (TBSA) (excluding upper and lower eyelids, mucosal lip areas, and forehead and chin areas covered by the stereotactic positioning device for photography) with at least one area of the face with normal pigmentation. Twenty-four eligible subjects will receive ATI-50002 Topical Solution, 0.46%, BID for 24 weeks.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study of the Safety, Tolerability and Efficacy of ATI-50002 Topical Solution Administered Twice-Daily in Adult Subjects With Non-Segmental Facial Vitiligo
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : November 12, 2018
Estimated Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: ATI-50002 Topical Solution
ATI-50002 topical solution, high dose active, twice-daily, 24 weeks
Drug: ATI-50002 topical solution
Topical Solution administered twice daily




Primary Outcome Measures :
  1. Percentage of facial repigmentation [ Time Frame: 24 weeks ]
    Percentage of facial repigmentation in quantified Area of Interest (AOI)


Secondary Outcome Measures :
  1. Subject satisfaction with repigmentation [ Time Frame: 24 weeks ]
    Subject assessment of satisfaction with study results using 7 point scale ranging from extremely satisfied to extremely dissatisfied

  2. Impact on subject quality of life [ Time Frame: 24 weeks ]
    Subject assessment using a 7 point Quality of Life questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has a clinical diagnosis of new onset or actively progressing non-segmental facial vitiligo or worsening of existing facial lesions within the past 6 months.
  2. Subject has non-segmental facial vitiligo effecting at least 0.25% total body surface area (TBSA) (excluding the upper and lower eyelids, mucosal lip areas and forehead and chin areas covered by the stereotactic positioning device for photography) with at least one area of the face with normal pigmentation.
  3. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit and must agree to use an approved method of highly effective birth control for the duration of the study and for 30 days after last study medication application.
  4. Subject is in good general health and free of any known disease state or physical condition which, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation.
  5. Subject agrees to refrain from any other treatments for vitiligo from the screening visit through the final follow-up visit. Over the counter (OTC) preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

  1. Subject with evidence of poliosis (white hairs) in > 50% of their facial vitiligo lesions.
  2. Subject with total facial depigmentation.
  3. Subject with spontaneous ongoing repigmentation (documented based on the subject's reporting in the last 3 months).
  4. Subject who has segmental vitiligo.
  5. Subject who has failed phototherapy. Failed phototherapy is defined as failure to achieve satisfactory repigmentation following adequately delivered phototherapy as determined by the investigator.
  6. Subject currently has, or has a history of, skin disease (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
  7. Subject has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (i.e.,renal disease), hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation.
  8. Subject currently has a history of, current, or suspected systemic or cutaneous malignancy and/or lymphoproliferative disease, other than a history of adequately treated, well healed and completely cleared non-melanoma skin cancers (e.g., basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.
  9. Subject currently has evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or a history of incompletely treated or untreated tuberculosis. Subjects who have initiated therapy for latent tuberculosis for at least 2 weeks and agree to continue their therapy through completion may participate.
  10. Subject has a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the baseline visit. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study.
  11. Subject has herpes zoster or cytomegalovirus (CMV) that resolved within 8 weeks prior to Visit 1.
  12. Subject has a history of frequent outbreaks of oral Herpes Simplex Virus defined as more than 4 episodes per year.
  13. Subjects previously treated with depigmenting agents.
  14. Clinically significant laboratory abnormalities at screening that in the opinion of the investigator, would make the subject a poor candidate for the study.
  15. Subject who has an absolute neutrophil count <1,000/mm3, or platelet count < 50,000/mL.
  16. Subject unable to comply with the required washout periods
  17. Subject who has participated in any investigational drug or device trial, regardless of indication in which administration of an investigational drug or device occurred within 30 days or 5 half-lives (whichever is longer) of screening (Visit 1). Note that investigational treatment for vitiligo (in any body area) requires a longer washout
  18. Subjects with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening. Subjects under treatment with stable thyroid replacement who have a free T4 and TSH within the normal range may participate.
  19. Subject has history of sensitivity to any of the ingredients in the study medication.
  20. Subject has a history of, or current alcohol or drug abuse within 2 years of study enrollment.
  21. Screening ECG findings of:

    1. QTcF >450msec for males or >470msec for females (use of the ECG algorithm is acceptable for this purpose)
    2. Heart rate ≤ 45 or ≥ 100 beats/minutes
    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 ClinicalTrials.gov identifier (NCT number): NCT03468855


Contacts
Contact: Susan Moran, MSN 484-329-2129 smoran@aclaristx.com

Locations
United States, California
Aclaris Investigator Site Recruiting
Encinitas, California, United States, 92024
Contact: Susan Moran, MSN         
Aclaris Investigator Site Recruiting
Los Angeles, California, United States, 90036
Contact: Susan Moran, MSN         
United States, Massachusetts
Aclaris Investigator Site Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Susan Moran, MSN         
United States, Texas
Aclaris Investigator Site Recruiting
Dallas, Texas, United States, 75390
Contact: Susan Moran, MSN         
United States, Virginia
Aclaris Investigator Site Recruiting
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Aclaris Therapeutics, Inc.

Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03468855     History of Changes
Other Study ID Numbers: ATI-50002-VITI-201
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Pharmaceutical Solutions