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

Phase 1

Completed

• Conditions: Seborrheic Keratosis (SK)
• Interventions: Drug: A-101 25%; Drug: A-101 32.5%; Drug: A-101 40%; Drug: A-101 Vehicle

• Registration Number: NCT01986920
• Lead Sponsor: Aclaris Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2013-10-22
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Primary Completion: 2014-02-25
• Study Completion: 2014-02-25
• Results First Submitted: 2017-01-09
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-15
• Last Update Submitted: 2018-11-15
• Results First Posted: 2018-12-11
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-101 25%	A-101 25%	Low dose group
A-101 32.5%	A-101 32.5%	Mid Dose Group
A-101 40%	A-101 40%	High Dose Group
A-101 Vehicle	A-101 Vehicle	Placebo group

Primary Outcome Measures

Name	Time	Method
Mean Change in Physician Lesion Assessment Scale	Visit 2 to visit 9 (78 days)	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.

Secondary Outcome Measures

Name	Time	Method
Subject's Self Assessment Scale	Visit 9 (Day 78)	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).

Trial Locations

Locations (1)

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States