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

• ClinicalTrials.gov Identifier: NCT01986920
• Recruitment Status: Completed
• First Posted: November 19, 2013
• Results First Posted: December 11, 2018
• Last Update Posted: December 11, 2018
• Sponsor: Aclaris Therapeutics, Inc.
• Information provided by (Responsible Party): Aclaris Therapeutics, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Seborrheic Keratosis (SK)	Drug: A-101 25%; Drug: A-101 32.5%; Drug: A-101 40%; Drug: A-101 Vehicle	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: October 22, 2013
• Actual Primary Completion Date: February 25, 2014
• Actual Study Completion Date: February 25, 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: A-101 25%; Low dose group	Drug: A-101 25%; Low Dose Concentration of A-101 applied to one of 4 Target Lesions
Active Comparator: A-101 32.5%; Mid Dose Group	Drug: A-101 32.5%; Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
Active Comparator: A-101 40%; High Dose Group	Drug: A-101 40%; High Dose Concentration A-101 applied to one of 4 Target Lesions
Placebo Comparator: A-101 Vehicle; Placebo group	Drug: A-101 Vehicle; Placebo applied to one of 4 Target Lesions

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Physician Lesion Assessment Scale [ Time Frame: 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 :

1. Subject's Self Assessment Scale [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Texas

DermResearch, Inc.

Austin, Texas, United States, 78759

Sponsors and Collaborators

Aclaris Therapeutics, Inc.

Investigators

• Principal Investigator: Janet Dubois, MD; Derm Research, PLLC

  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] September 24, 2013

More Information

Additional Information:

Study Sponsor Website 

• Responsible Party: Aclaris Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01986920
• Other Study ID Numbers: A-101-SEBK-201
• First Posted: November 19, 2013
• Results First Posted: December 11, 2018
• Last Update Posted: December 11, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Aclaris Therapeutics, Inc.:

SK; Seborrheic Keratosis

Additional relevant MeSH terms:

Keratosis, Actinic; Keratosis; Keratosis, Seborrheic; Skin Diseases; Precancerous Conditions; Neoplasms