Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

NCT01986920 | Completed Phase 1 Results

• 1 other identifier: A-101-SEBK-201
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.

Conditions

Seborrheic Keratosis (SK)

Keywords

SK; Seborrheic Keratosis

Outcome Measures

Primary Outcomes (1)

• Mean Change in Physician Lesion Assessment Scale

  Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.

  Visit 2 to visit 9 (78 days)

Secondary Outcomes (1)

• Subject's Self Assessment Scale

  Visit 9 (Day 78)

Study Arms (4)

A-101 25%

ACTIVE COMPARATOR

Low dose group

Drug: A-101 25%

A-101 32.5%

ACTIVE COMPARATOR

Mid Dose Group

Drug: A-101 32.5%

A-101 40%

ACTIVE COMPARATOR

High Dose Group

Drug: A-101 40%

A-101 Vehicle

PLACEBO COMPARATOR

Placebo group

Drug: A-101 Vehicle

Interventions

A-101 25% DRUG

Low Dose Concentration of A-101 applied to one of 4 Target Lesions

A-101 25%

A-101 32.5% DRUG

Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

A-101 32.5%

A-101 40% DRUG

High Dose Concentration A-101 applied to one of 4 Target Lesions

A-101 40%

A-101 Vehicle DRUG

Placebo applied to one of 4 Target Lesions

A-101 Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years of age
• Has a clinical diagnosis of stable clinically typical seborrheic keratosis
• Has at least 4 appropriate seborrheic keratosis target lesions on the back
• If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
• Is non-pregnant and non-lactating
• Is in good general health and free of any disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation
• Is willing and able to follow all study instructions and to attend all study visits
• Is able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if:

• Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
• Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
• Has used any of the following systemic therapies within the specified period prior to Visit 1:
• Retinoids; 180 days
• Glucocorticosteroids; 28 days
• Anti-metabolites (e.g., methotrexate); 28 days
• Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
• Retinoids; 90 days
• Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
• Glucocorticosteroids or antibiotics; 14 days
• Moisturizers/emollients, sunscreens; 12 hours
• Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
• Has a history of keloid formation or hypertrophic scarring
• Has a current systemic malignancy
• Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (1)

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Related Links

• Study Sponsor Website

MeSH Terms

Conditions

Keratosis, Seborrheic

Interventions

N-phenylacetoaminomethylene-DL-p-nitrophenylalanine

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Since each patient simultaneously participates in all four treatment groups only skin site related adverse events are reported by treatment group. Systemic adverse events are reported in all treatment groups the same.

Results Point of Contact

• Title: Christopher Powala, Chief Operating Officer
• Organization: Aclaris Therapeutics

cpowala@aclaristx.com

484-324-7933

Study Officials

• Janet Dubois, MD

  Derm Research, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The three tests solutions and the placebo solution are each applied topically to 1 of 4 target lesions on the backs of each subject (determined by the randomization schedule). If needed a second treatment may be applied at Visit 5.

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 19, 2013
• Study Start: October 22, 2013
• Primary Completion: February 25, 2014
• Study Completion: February 25, 2014
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)