Alopecia AreataPhase 2NCT03551821
Open Label Study of ATI-50002 Topical Solution Administered to Adult Subjects With Eyebrow Loss Due to Alopecia Areata
A Phase 2 study testing ATI-50002 in people with Alopecia Areata and Alopecia Totalis, run by Aclaris Therapeutics, Inc. at 1 site in United States.
Trial summary
The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution in subjects with unilateral or bilateral loss of eyebrow hair due to alopecia areata (AA), alopecia universalis (AU) or alopecia totalis (AT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- ATI-50002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 6 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age.
- Subject has, based on a subject history and clinical examination, a clinical diagnosis of AA, AU or AT with no eyebrow hair in the affected area(s) and no eyebrow regrowth over the previous 6 months. Affected area is defined as the area(s) of eyebrow hair loss identified at Baseline.
- Subject has a Clinician Eyebrow Assessment score of 0 for at least one eyebrow.
- Subject has a Subject Eyebrow Assessment score of 0 for at least one eyebrow.
- Subject has a duration of the current episode of AA, AU or AT with unilateral or bilateral loss of eyebrow hairs (with at least one distinct patch of >30% loss of eyebrow hair) for at least 6 months and no more than seven years prior to Visit 1.
- Subjects who are Women 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 and for 30 days after last study medication application.
Show all 15Show fewer
- Subject is non-pregnant and non-lactating and not planning a pregnancy during the duration of the study and for 30 days after the 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 requirements or put the subject at undue risk by study participation.
- Subject is willing and able to follow all study instructions and to attend all study visits.
- Subjects taking hormonal replacement therapy must have been on the same dose for at least 6 months prior to Visit 1 and must agree to maintain the same dose for the duration of the study and for 90 days after the last study medication application.
- Subjects taking thyroid replacement therapy must have been on the same dose for at least 6 months prior to Visit 1 and must agree to maintain the same dose for the duration of the study.
- Subject agrees to refrain from any eyebrow removal (e.g.¸ plucking, threading, etc.) for the duration of the study.
- Subject agrees to refrain from any cosmetic surgery (e.g., piercing, tattooing, etc.), on the treatment areas, for the duration of the study.
- Subject can comprehend and is willing to sign an Informed Consent Form (ICF).
- 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
Who cannot join
- Subject has, in the opinion of the investigator, permanent eyebrow loss attributed to causes other than AA, AU or AT such as overgrooming, or scarring hair loss.
- Subject currently has, or has a history of, skin disease in the eyebrow area (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
- Subject currently has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, endocrinologic, 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, put the subject at undue risk by study participation.
- Subject currently has, or has a history of, proven 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 one year prior to Visit 1.
- Subject currently has evidence of active or latent bacterial infection, including tuberculosis, or viral infections at the time of enrollment or a history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.
- Subject has a history of serious local infection (e.g., cellulitis, abscess) or a systemic infection, including but not limited to, pneumonia or septicemia, within 12 weeks prior to Visit 1. Subjects on an antibiotic for a nonserious, acute local infection must complete the antibiotic course prior to enrollment in the study.
Show all 35Show fewer
- Subjects positive for HIV, Hepatitis B or C.
- Subject currently has or has a known history of herpes zoster or cytomegalovirus (CMV) within 8 weeks prior to Visit 1.
- Subject has a history of frequent outbreaks of Herpes Simplex Virus defined as 4 or more episodes per year.
- Subject has any history of eyebrow tattooing, or microblading that in the opinion of the investigator would interfere with the assessment of safety or efficacy.
- Subject has used any semi-permanent eyebrow coloring (e.g., tinting, dying, etc.) within 6 months prior to Visit 1 that in the opinion of the investigator would interfere with the assessment of safety or efficacy.
- Clinically significant laboratory abnormalities at Screening that, in the opinion of the Investigator, would make the subject a poor candidate for the study.
- Subjects with absolute neutrophil count <1,000/mm3, or platelet count <50,000/ml.
- Subject used any of the following therapies within the specified period prior to Visit 1:
- Systemic therapies:
- Disease Modifying Anti-Rheumatic Drugs (DMARDS), Biologics or immunosuppressants, such as: anakinra, adalimumab, azathioprine, glucocorticosteroids, cyclosporine, etanercept, infliximab, methotrexate, TNF inhibitors, ustekinumab, secukinumab, ixekizumab, certolizumab pegol: 4 weeks or 5 half-lives whichever is longer
- Oral retinoids: 12 weeks
- Plaquenil: 8 weeks
- JAK inhibitors (oral or topical): 1 year
- Intralesional steroids on the eyebrow area: 4 weeks
- Topical therapies on the eyebrow area:
- Phototherapy, Laser Therapy : 12 weeks
- Anthralin, bimatoprost, glucocorticosteroids, diphencyprone, diphenylcycloprophenone (DPCP), Squaric acid dibutyl ester (SADBE), minoxidil, pimecrolimus, tacrolimus: 4 weeks
- Topical treatments (prescription and over-the-counter) that contain retinoids, retinol, alpha hydroxy acids (e.g. glycolic, lactic acids) and beta hydroxy acids (e.g. salicylic acid) on and around the eyebrow area: 4 weeks
- Subject has a history of sensitivity to any of the ingredients in the study medication.
- Subject has participated in an investigational drug or device trial in which administration of an investigational study drug or device occurred within 30 days or 5 half-lives (whichever is longer) prior to Visit 1. Subjects who have participated in a study of an investigational drug, device or biologic agent for alopecia areata (AA, AU or AT) within 1 year of screening will be eligible to participate only with individual permission from the Medical Monitor.
- History of or current alcohol or drug abuse within 2 years of assessment for 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 (inclusive)
- 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
1 site in 1 country.
United States1 site
Aclaris Investigator Site
Boynton Beach, Florida, 33472
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 Eyebrow Loss Due to Alopecia Areata, Alopecia Universalis or Alopecia Totalis
The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution in subjects with unilateral or bilateral loss of eyebrow hair due to alopecia areata (AA), alopecia universalis (AU) or alopecia totalis (AT).
Read the detailed description
This is an open-label study which will be conducted at 1 to 2 sites.
Subjects will be required to have a clinical diagnosis of AA, AU or AT with unilateral or bilateral loss of eyebrow hair.
Subjects will apply study medication to the entire affected eyebrow(s), twice-daily for 24 weeks.
Safety and tolerability will be evaluated throughout the study.
The duration of the study participation is anticipated to be a maximum of 233 days.
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Being tested
- ATI-50002
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-50002Drug
Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| ATI-50002 Topical Solution | Experimental | ATI-50002 Topical Solution Receives: Drug: ATI-50002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's Eyebrow Assessment
Determination of the amount of hair in the affected area.
Clinician's Eyebrow Assessment
Grade Descriptor 0 No eyebrow hair: No terminal hairs are visible in the affected area(s)
- A little eyebrow hair: Occasional terminal hairs are visible in the affected area(s)
- Some eyebrow hair: Numerous terminal hairs are visible in the affected area(s)
- Most eyebrow hair: Mostly complete eyebrow regrowth with terminal hair in the affected area(s)
- Full eyebrow hair: Complete eyebrow regrowth with terminal hair in the affected area(s)
Measured: Six months
Secondary outcomes (1)
Subject's Eyebrow Assessment
Determination of the amount of hair in the affected area.
Subject's Eyebrow Assessment Grade Descriptor 0 No eyebrow hair: No thick, coarse hairs are visible in the affected area(s)
- A little eyebrow hair: A few thick, coarse hairs are visible in the affected area(s)
- Some eyebrow hair: Numerous thick, coarse hairs are visible in the affected area(s)
- Most eyebrow hair: The majority of the affected area(s) of the eyebrow is covered in thick, coarse hairs
- Full eyebrow hair: The affected area(s) of the eyebrow is fully covered in thick, coarse hairs
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start11 Apr 2018
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551821
- Sponsor's protocol ID
- ATI-50002-AAB-201
- Status last verified
- Oct 2019
- First submitted
- 17 May 2018
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Eyebrow Loss Due to Alopecia Areata, Alopecia Universalis or Alopecia Totalis
- ClinicalTrials.gov ID
- NCT03551821
- Acronym / sponsor ID
- ATI-50002-AAB-201
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Posted 11 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution in subjects with unilateral or bilateral loss of eyebrow hair due to alopecia areata (AA), alopecia universalis (AU) or alopecia totalis (AT).
Detailed description
This is an open-label study which will be conducted at 1 to 2 sites.
Subjects will be required to have a clinical diagnosis of AA, AU or AT with unilateral or bilateral loss of eyebrow hair.
Subjects will apply study medication to the entire affected eyebrow(s), twice-daily for 24 weeks.
Safety and tolerability will be evaluated throughout the study.
The duration of the study participation is anticipated to be a maximum of 233 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATI-50002 Topical Solution | Experimental | Drug: ATI-50002ATI-50002 Topical Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is at least 18 years of age.
- Subject has, based on a subject history and clinical examination, a clinical diagnosis of AA, AU or AT with no eyebrow hair in the affected area(s) and no eyebrow regrowth over the previous 6 months. Affected area is defined as the area(s) of eyebrow hair loss identified at Baseline.
- Subject has a Clinician Eyebrow Assessment score of 0 for at least one eyebrow.
- Subject has a Subject Eyebrow Assessment score of 0 for at least one eyebrow.
- Subject has a duration of the current episode of AA, AU or AT with unilateral or bilateral loss of eyebrow hairs (with at least one distinct patch of >30% loss of eyebrow hair) for at least 6 months and no more than seven years prior to Visit 1.
Key exclusion criteria (35 listed)
- Subject has, in the opinion of the investigator, permanent eyebrow loss attributed to causes other than AA, AU or AT such as overgrooming, or scarring hair loss.
- Subject currently has, or has a history of, skin disease in the eyebrow area (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
- Subject currently has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, endocrinologic, 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, put the subject at undue risk by study participation.
- Subject currently has, or has a history of, proven 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 one year prior to Visit 1.
- Subject currently has evidence of active or latent bacterial infection, including tuberculosis, or viral infections at the time of enrollment or a history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy for latent tuberculosis may participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATI-50002Topical Solution | Drug | ATI-50002 Topical Solution |
Primary outcome
Clinician's Eyebrow Assessment
Time frame: Six months
Determination of the amount of hair in the affected area. Clinician's Eyebrow Assessment Grade Descriptor 0 No eyebrow hair: No terminal hairs are visible in the affected area(s) 1. A little eyebrow hair: Occasional terminal hairs are visible in the affected area(s) 2. Some eyebrow hair: Numerous terminal hairs are visible in the affected area(s) 3. Most eyebrow hair: Mostly complete eyebrow regrowth with terminal hair in the affected area(s) 4. Full eyebrow hair: Complete eyebrow regrowth with terminal hair in the affected area(s)
1 secondary outcome
Subject's Eyebrow Assessment
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alopecia Areata
Not yet recruitingPhase 3
Clinical Study of DA-007 for the Treatment of Chemotherapy Induced Alopecia
Chemotherapy Induced Alopecia, Chemotherapy Side Effects
Active, not recruitingPhase 3
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Androgenetic Alopecia, Female Pattern Baldness
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
Alopecia Areata
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATI-50002 in people with Alopecia Areata and Alopecia Totalis, run by Aclaris Therapeutics, Inc. at 1 site 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 15 inclusion and 35 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Dec 2019). 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?
Clinician's Eyebrow Assessment (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2019.