Phase 2
Completed N=11
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
Alopecia Universalis (AU) · Alopecia Totalis (AT)
Source: ClinicalTrials.gov NCT03315689 ↗
Enrolled (actual)
11
Serious AEs
4.8%
Results posted
Jul 2020
Primary outcomePrimary: Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 — 166.0; 579.7; NA; 5710.0 ng/g
Summary
The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29 |
166.0; 579.7; NA; 5710.0 | — |
| SECONDARY Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 52 |
-15.0 | — |
| SECONDARY Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 40 |
-8.8 | — |
| SECONDARY Open Label Extension: Mean Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 28 |
-6.1 | — |
| SECONDARY Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 28 |
-7.1 | — |
| SECONDARY Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 40 |
-9.5 | — |
| SECONDARY Open Label Extension: Change From Baseline in Alopecia Density and Extent Score (ALODEX) at Week 52 |
-12.0 | — |
| SECONDARY Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 28 |
0.4 | — |
| SECONDARY Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 40 |
0.5 | — |
| SECONDARY Open Label Extension: Mean Change in Subject's Eyebrow Assessment (SEA) at Week 52 |
0.6 | — |
| SECONDARY Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 28 |
0.1 | — |
| SECONDARY Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 40 |
0.6 | — |
| SECONDARY Open Label Extension: Mean Change in Clinician's Eyebrow Assessment (CEA) at Week 52 |
0.8 | — |
| SECONDARY Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 28 |
0; 2; 1; 1; 0; 1 | — |
| SECONDARY Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 40 |
0; 2; 0; 1; 0; 0 | — |
| SECONDARY Open Label Extension: Subject Global Impression of Treatment Satisfaction (SGIS) Week 52 |
0; 2; 0; 1; 0; 0 | — |
| SECONDARY Open Label Extension: Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 24 From Baseline |
6.3 | — |
| SECONDARY Open Label Extension: Severity of Alopecia Tool (SALT Scores), Relative Percent Regrowth (%) at Week 40 From Baseline |
9.0 | — |
| SECONDARY Open Label Extension: The Severity of Alopecia Tool (SALT) Scores, Relative Percent Regrowth (%) at Week 52 From Baseline |
15.5 | — |
| SECONDARY Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 24 Weeks |
7.2 | — |
| SECONDARY Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 40 Weeks |
9.6 | — |
| SECONDARY Open Label Extension: The Alopecia Density and Extent (ALODEX) Scores, Relative Percent Regrowth (%) at 52 Weeks |
12.2 | — |
Eligibility Criteria
Inclusion Criteria
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent.
- Have a clinical diagnosis of stable, clinically typical, AU or AT.
- Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years.
- Be willing and able to follow all study instructions and to attend all study visits.
Exclusion Criteria
- Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication.
- Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).
- Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
- Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations.
- The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
Data sourced from ClinicalTrials.gov (NCT03315689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.