Seborrheic Keratosis (SK) Clinical Trial
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
| Verified date | November 2018 |
| Source | Aclaris Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | February 25, 2014 |
| Est. primary completion date | February 25, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | DermResearch, Inc. | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Aclaris Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Subject's Self Assessment Scale | Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3). | Visit 9 (Day 78) |