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VitiligoPhase 2NCT03468855

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

A Phase 2 study testing ATI-50002 topical solution in people with Vitiligo, run by Aclaris Therapeutics, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Vitiligo
What is being tested?
ATI-50002 topical solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
5 sitesUnited States
Study dates
19 Mar 2018to 16 Oct 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Subject with evidence of poliosis (white hairs) in > 50% of their facial vitiligo lesions.
  • Subject with total facial depigmentation.
  • Subject with spontaneous ongoing repigmentation (documented based on the subject's reporting in the last 3 months).
  • Subject who has segmental vitiligo.
  • Subject who has failed phototherapy. Failed phototherapy is defined as failure to achieve satisfactory repigmentation following adequately delivered phototherapy as determined by the investigator.
  • 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.
Show all 28Show fewer
  • 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.
  • 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.
  • 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.
  • 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.
  • Subject has herpes zoster or cytomegalovirus (CMV) that resolved within 8 weeks prior to Visit 1.
  • Subject has a history of frequent outbreaks of oral Herpes Simplex Virus defined as more than 4 episodes per year.
  • Subjects previously treated with depigmenting agents.
  • Clinically significant laboratory abnormalities at screening that in the opinion of the investigator, would make the subject a poor candidate for the study.
  • Subject who has an absolute neutrophil count <1,000/mm3, or platelet count < 50,000/mL.
  • Subject unable to comply with the required washout periods
  • 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
  • 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.
  • Subject has history of sensitivity to any of the ingredients in the study medication.
  • Subject has a history of, or current alcohol or drug abuse within 2 years of study enrollment.
  • Screening ECG findings of:
  • QTcF >450msec for males or >470msec for females (use of the ECG algorithm is acceptable for this purpose)
  • Heart rate ≤ 45 or ≥ 100 beats/minutes
  • Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm (ectopic atrial rhythm)
  • Conduction disturbance including PR >240msec, pre-excitation (delta wave and PR <120msec), second degree or higher AV block
  • Acute or chronic signs of ischemia.
  • Left Bundle Branch Block
  • Prior myocardial infarction

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Aclaris Investigator Site

    Dallas, Texas, 75390

  • Aclaris Investigator Site

    Encinitas, California, 92024

  • Aclaris Investigator Site

    Los Angeles, California, 90036

  • Aclaris Investigator Site

    Lynchburg, Virginia, 24501

  • Aclaris Investigator Site

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Vitiligo
Being tested
ATI-50002 topical solution
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATI-50002 topical solutionDrug

    Topical Solution administered twice daily

Study groups in NCT03468855
Study groupRoleWhat they receive
ATI-50002 Topical SolutionExperimentalATI-50002 topical solution, high dose active, twice-daily, 24 weeks
Receives: Drug: ATI-50002 topical solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 24 Weeks

Secondary outcomes (30)

  1. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 48. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 48 Weeks

  2. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 4 Weeks

  3. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 8. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 8 Weeks

  4. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 12. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 12 Weeks

  5. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 16 Weeks

  6. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Visit 2 Compared to Week 20

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 20. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 20 Weeks

  7. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 32

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 4. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 32 Weeks

  8. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 40

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 40. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 40 Weeks

  9. Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Post-treatment Week 52

    Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 52. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 52 Weeks

  10. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 4

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 4. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 4 Weeks

  11. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 8

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at Week 8. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 8 Weeks

  12. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 12

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 12. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 12 Weeks

  13. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 16

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 16. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Week 16

  14. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 20

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 20. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 20 Weeks

  15. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 24

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 24. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 24 Weeks

  16. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 32

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 32. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 32 Weeks

  17. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 40

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 40. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 40 Weeks

  18. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Week 48

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 48. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 48 Weeks

  19. Mean Change From Baseline in the Facial Assessment of the Vitiligo Area Scoring Index (F-VASI) Compared to Post-treatment Week 52

    The Facial Vitiligo Area Scoring Index (F-VASI) is an assessment of the subject's facial vitiligo modified from the Vitiligo Area Scoring Index for the face only at week 52. F-VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 52 Weeks

  20. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 4

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 4 Weeks

  21. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 8

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 8 Weeks

  22. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 12

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 12 Weeks

  23. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 16

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 16 Weeks

  24. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 20

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 20 Weeks

  25. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 24

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 24 Weeks

  26. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 32

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 32 Weeks

  27. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 40

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 40 Weeks

  28. Treatment Success Based on the Subject's Assessment of Vitiligo on the Vitiligo Noticeability Scale (VNS) at Week 48

    The Vitiligo Noticeability Scale (VNS) represents the subject's assessment of the noticeability of facial vitiligo during the study treatment period by means of answering the question, "Compared to before treatment, how noticeable is the vitiligo now?" Subject response options include, "1: More Noticeable", "2: As Noticeable", "3: Slightly Less Noticeable", "4: A Lot Less Noticeable", and "5: No Longer Noticeable". Treatment success will be defined as follows: VNS score of 1 or 2 = treatment not successful, VNS score of 3 = treatment partially successful, or VNS score of 4 or 5 = treatment successful. Higher scores represent better outcomes.

    Measured: Baseline to 48 Weeks

  29. Mean Change From Baseline in Total VASI at Week 24

    The Vitiligo Area Scoring Index (VASI) is an assessment of the subject's Vitiligo Area Scoring Index. VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 24 Weeks

  30. Mean Change From Baseline in Total VASI at Week 48

    The Vitiligo Area Scoring Index (VASI) is an assessment of the subject's Vitiligo Area Scoring Index. VASI is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

    Measured: Baseline to 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start19 Mar 2018
  3. Primary completion16 Oct 2019
  4. Study completion16 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468855
Sponsor's protocol ID
ATI-50002-VITI-201
Status last verified
Nov 2020
First submitted
12 Feb 2018
Last updated
30 Nov 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATI-50002 topical solution in people with Vitiligo, run by Aclaris Therapeutics, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24 (time frame: Baseline to 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03468855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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