A Phase 4 interventional study of A-101 Topical Solution in Seborrheic Keratosis, sponsored by Aclaris Therapeutics, Inc.. Completed at 3 sites in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by Aclaris Therapeutics, Inc. · Phase 4, Interventional, and Treatment
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Among 15 studies in Keratosis, Seborrheic with a site in United States — 2 open to participants now, 2 under way, 1 of them phase 3. Keratosis, Seborrheic · United States.
Among the 15 studies in Keratosis, Seborrheic with a site in United States, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2018, is the only one in phase 4, and was the 11th registered.
29 studies on the registry are indexed under Keratosis, Seborrheic; 3 are open to participants now.
Browse Keratosis, Seborrheic studies →2 of the 15 studies in Keratosis, Seborrheic with a site in United States are open now. Recruiting first, the newest first:
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
DermBiont, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 2 Keratosis, Seborrheic studies recruiting now, 2 set no upper age limit and none stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 30 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 4 · Phase 4 1
First in 1999; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 65 across 20 interventional studies indexed under Keratosis, Seborrheic.
Median enrollment 133 across the 14 interventional studies, 113 across the 1 observational. Of the 13 that completed or were terminated, 10 (77%) have results posted.
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11 of 15 have an industry lead sponsor. The 7 most frequent:
Aclaris Therapeutics, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.
Aclaris Therapeutics, Inc. has 8 studies filed under Keratosis, Seborrheic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Keratosis, Seborrheic with a site in United States, from their registry updates:
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This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open Label Arm
Drug: A-101 Topical Solution
A-101 Topical Solution applied Day 1, Day 15 and Day 29
Subject Satisfaction
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
Time frame: Day 113
Effectiveness of Treatment
Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness \</= 1 mm); PLA=3 (Thick; thickness \> 1 mm).
Time frame: Day 113
Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.
Time frame: Day 113
| Milestone | A-101 Topical Solution |
|---|---|
| Started | 41 |
| Completed | 41 |
| Not completed | 0 |
Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution
| Participants | A-101 Topical Solution |
|---|---|
| very satisfied (5) | 21 |
| satsified (4) | 14 |
| moderately satisfied (3) | 4 |
| slightly satisfied (2) | 0 |
| not satisfied at all (1) | 2 |
Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness \</= 1 mm); PLA=3 (Thick; thickness \> 1 mm).
| score on a scale (PLA) | A-101 Topical Solution |
|---|---|
| Effectiveness of Treatment | -2.0 ± 0.62 |
Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.
| point bi-serial correlation coefficient | A-101 Topical Solution |
|---|---|
| Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction | .318 |
Collected over 17 weeks; The reporting period for SAEs began when the subject signed the informed consent form. Non serious clinical AEs were collected following the application of the study drug at Visit 2 and continued through Visit 11. All safety reporting (AEs and SAEs) was concluded at Visit 11 (Day 113).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A-101 Topical Solution | 0/41 (0%) | 0/41 (0%) | 8/41 (19.5%) |
| Event | A-101 Topical Solution |
|---|---|
| Eyelid OedemaEye disorders | 2/41 |
| Administration site discomfortGeneral disorders | 1/41 |
| Administration site irritationGeneral disorders | 1/41 |
| Arthropod stingInjury, poisoning and procedural complications | 1/41 |
| FallInjury, poisoning and procedural complications | 1/41 |
| Blood cholesterol increasedInvestigations | 1/41 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/41 |
| Tooth extractionSurgical and medical procedures | 1/41 |
| Age, Continuous(years) | A-101 Topical Solution |
|---|---|
| Mean | 62.4 ± 6.97 |
| Sex: Female, Male(Participants) | A-101 Topical Solution |
|---|---|
| Female | 24 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | A-101 Topical Solution |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 41 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | A-101 Topical Solution |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 41 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | A-101 Topical Solution |
|---|---|
| United States | 41 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Nov 2018, 7 months.
Results were first posted in Oct 2019, 10 months after primary completion.
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Studies of the drug tested here: N-phenylacetoaminomethylene-DL-p-nitrophenylalanine