Clinical trial NCT02667275: A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
Official title: A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seborrheic Keratosis
Keywords: seborrheic keratosis
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-28
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years of age
2. Clinical diagnosis of stable clinically typical seborrheic keratosis
3. 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
4. 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
5. Subject is non-pregnant and non-lactating
6. 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
7. Subject is willing and able to follow all study instructions and to attend all study visits
8. Subject is able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria:

1. 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.

Primary outcomes:
measure: Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale
timeFrame: Study day 106
Secondary outcomes:
measure: Percent of Lesions Cleared Scale
timeFrame: Study day 106
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Aclaris Therapeutics, Inc.
state: Pennsylvania
Study officials:
affiliation: Aclaris Therapeutics, Inc.
name: Stuart D Shanler, MD
role: STUDY_DIRECTOR
References:
citation: 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.