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Also known as A-101 Topical Solution, A-101 (40) Topical Solution, A-101 Solution, hydrogen peroxide 45%
A-101 · 10 trials · 2 indications
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks.
The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.
Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and \< 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length)
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and \< 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length)
Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8 Grade Descriptor 0 Clear: no visible seborrheic keratosis lesion 1. Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated) 2. Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm) 3. Thick: a visible seborrheic keratosis lesion (thickness \> 1 mm)
The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.
Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.
| Arm | Type | Description |
|---|---|---|
| A-101 | EXPERIMENTAL | Topical Solution |
| Vehicle | OTHER | topical solution |
| A-101 Solution | ACTIVE_COMPARATOR | A-101 Solution 40% administered once |
| Vehicle Solution | PLACEBO_COMPARATOR | Vehicle Solution administered once |
| Active | EXPERIMENTAL | A-101 Topical Solution |
| A-101 Low Dose | ACTIVE_COMPARATOR | A-101 Low Dose Topical Solution |
| A-101 High Dose | ACTIVE_COMPARATOR | A-101 High DoseTopical Solution |
| A-101 40% | ACTIVE_COMPARATOR | A-101 40% Topical Solution |
| A-101 32.5% | ACTIVE_COMPARATOR | A-101 32.5% Topical Solution |
| A-101 Vehicle Topical Solution | PLACEBO_COMPARATOR | A-101 0% Topical Solution (vehicle) |
| A-101 Vehicle | PLACEBO_COMPARATOR | A-101 Vehicle (placebo) Topical Solution |
| A-101 (40) Topical Solution | ACTIVE_COMPARATOR | A-101 (40) Topical Solution - high dose |
| A-101 (32.5) Topical Solution | ACTIVE_COMPARATOR | A-101 (32.5) Topical Solution - low dose |
| Name | Type | Description |
|---|---|---|
| A-101 | DRUG | hydrogen peroxide topical solution 45% |
| vehicle | OTHER | vehicle as a topical solution |
| A-101 Solution | DRUG | Active Drug |
| Vehicle Solution | OTHER | Placebo |
| A-101 Topical Solution | DRUG | A-101 Topical Solution |
| A-101 Vehicle Solution | DRUG | A-101 Vehicle Solution |
| A-101 Vehicle | DRUG | Placebo control |
| A-101 (40) Topical Solution | DRUG | A-101 (40) Topical Solution - high dose |
| A-101 (32.5) Topical Solution | DRUG | A-101 (32.5) Topical Solution - low dose |
Inclusion Criteria: * Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study. * Subject must have completed study participation in either A-101-WART-301 or A-101-WART-302. * Male or female ≥ 1 years old. * Subject has a clin...
A-101 is an investigational small molecule topical solution being developed by Aclaris Therapeutics, Inc. for the treatment of common warts and seborrheic keratosis. It is applied directly to the skin lesion and is currently in Phase 3 clinical development. It has not been approved by the FDA.
A-101 is being studied for the treatment of common warts and seborrheic keratosis, two common skin conditions. Clinical trials have enrolled patients with common warts, including adults and children as young as 1 year old. The seborrheic keratosis indication is also part of the development program.
A-101 is developed by Aclaris Therapeutics, Inc., which trades on the Nasdaq under the ticker ACRS. The company is the sponsor of the clinical trial program evaluating A-101 Topical Solution for common warts and seborrheic keratosis.
A-101 is in Phase 3 clinical development. Six clinical trials have been completed, including two Phase 3 studies and two Phase 2 studies in common warts, with a total enrollment of 1,628 participants. No trials are currently active. A-101 is investigational and has not been approved by the FDA.
A-101 has been evaluated in completed trials including NCT03812510, a Phase 3 safety study in common warts with 426 participants, and NCT03687372, a Phase 3 study in common warts with 503 participants. Earlier Phase 2 trials include NCT03278028 with 159 participants and NCT03210337 with 157 participants. All were conducted in the United States.
Yes. A-101, A-101 Topical Solution, A-101 (40) Topical Solution, and A-101 Solution all refer to the same investigational product developed by Aclaris Therapeutics. The different names reflect the formulation and concentration used across the clinical development program for common warts and seborrheic keratosis.