A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis

NCT02667275 | Completed Phase 3 Results

• 1 other identifier: A-101-SEBK-302
• Study Type: interventional
• Target: 487
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, vehicle-controlled, parallel group study.

Conditions

Seborrheic Keratosis

Keywords

seborrheic keratosis

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale

  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.

  Study day 106

Secondary Outcomes (1)

• Percent of Lesions Cleared Scale

  Study day 106

Study Arms (2)

A-101 Solution

EXPERIMENTAL

A-101 Solution 40% administered once

Drug: A-101 Solution

Vehicle Solution

PLACEBO COMPARATOR

Vehicle Solution administered once

Other: Vehicle Solution

Interventions

A-101 Solution DRUG

A-101 Solution

Vehicle Solution OTHER

Placebo

Vehicle Solution

Eligibility Criteria

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

You may qualify if:

• Subject is at least 18 years of age
• Clinical diagnosis of stable clinically typical seborrheic keratosis
• Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:
• Have a clinically typical appearance
• Have a PLA of 2 or greater and be a discrete lesion
• Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
• Not be in an intertriginous fold
• Not be on the eyelids
• Not be within 5mm of the orbital rim
• Not be pedunculated
• If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active method of birth control for the duration of the study
• Subject is non-pregnant and non-lactating
• Subject is in good general health and free of any known 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
• Subject is willing and able to follow all study instructions and to attend all study visits
• Subject is able to comprehend and willing to sign an Informed Consent Form.

You may not qualify if:

• \. Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions 2. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat) 3. Subject has a current systemic malignancy 4. Subject has used any of the following systemic therapies within the specified period prior to enrollment:
• Retinoids; 180 days
• Glucocortico-steroids;
• Anti-metabolites (e.g., methotrexate); 5. Subject has used any of the following topical therapies within the specified period or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
• LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy;
• Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate;
• Retinoids;
• Microdermabrasion or superficial chemical peels;
• Glucocortico-steroids or antibiotics 6. Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
• A cutaneous malignancy;
• A sunburn; currently
• A pre-malignancy (e.g., actinic keratosis); currently
• Body art (e.g., tattoos, piercing, etc.); currently
• Excessive tan; currently 7. Subject has a history of sensitivity to any of the ingredients in the study medications 8. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations 9. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (1)

Aclaris Therapeutics, Inc.

Malvern, Pennsylvania, 19355, United States

Location

Related Publications (1)

• Smith SR, Xu S, Estes E, Shanler SD. Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies. J Drugs Dermatol. 2018 Oct 1;17(10):1092-1098.

  PMID: 30365590 DERIVED

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Judy Schnyder, Sr. Director Clinical Operations
• Organization: Aclaris Therapeutics

jschnyder@aclaristx.com

484-329-2144

Study Officials

• Stuart D Shanler, MD

  Aclaris Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 6, 2018
• Results First Posted: November 13, 2017

Record last verified: 2016-01

Locations

US (1)