Clinical trial NCT01986920: Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seborrheic Keratosis (SK)
Keywords: SK
Seborrheic Keratosis
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed description: The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.

Eligibility criteria: Inclusion Criteria:

1. Is at least 18 years of age
2. Has a clinical diagnosis of stable clinically typical seborrheic keratosis
3. Has at least 4 appropriate seborrheic keratosis target lesions on the back
4. 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
5. Is non-pregnant and non-lactating
6. 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
7. Is willing and able to follow all study instructions and to attend all study visits
8. Is able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

1. Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
2. Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
3. 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
4. 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
5. 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
6. Has a history of keloid formation or hypertrophic scarring
7. Has a current systemic malignancy
8. Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area
9. Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
10. Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
11. Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
12. Has experienced a sunburn on the treatment area within the previous 4 weeks
13. Has a history of sensitivity to any of the ingredients in the study medications
14. Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
15. Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Primary outcomes:
measure: Mean Change in Physician Lesion Assessment Scale
timeFrame: Visit 2 to visit 9 (78 days)
Secondary outcomes:
measure: Subject's Self Assessment Scale
timeFrame: Visit 9 (Day 78)
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
affiliation: Derm Research, PLLC
name: Janet Dubois, MD
role: PRINCIPAL_INVESTIGATOR
References: