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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01986920
First received: November 6, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Seborrheic Keratosis
Drug: A-101 25%
Drug: A-101 32.5%
Drug: A-101 40%
Drug: A-101 Vehicle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Aclaris Therapeutics, Inc.:

Primary Outcome Measures:
  • Physician Lesion Assessment Scale [ Time Frame: Day 78 ] [ Designated as safety issue: No ]
    Physician's subjective assessment of the condition of the lesion


Secondary Outcome Measures:
  • Subject's Self Assessment Scale [ Time Frame: Day 78 ] [ Designated as safety issue: No ]
    Subjects assessment of the condition of their lesions


Estimated Enrollment: 36
Study Start Date: November 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A-101 25%
Low dose group
Drug: A-101 25%
Low Dose Concentration of A-101
Active Comparator: A-101 32.5%
Mid Dose Group
Drug: A-101 32.5%
Mid Dose Concentration of A-101
Active Comparator: A-101 40%
High Dose Group
Drug: A-101 40%
High Dose Concentration A-101
Placebo Comparator: A-101 Vehicle
Placebo group
Drug: A-101 Vehicle
Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 Lesser-Trelat) 
  3. Has used any of the following systemic therapies within the specified period prior to Visit 1:

    • Retinoids; 180 days
    • Glucocortico-steroids; 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, electrodessication, curettage, imiquimod, 5-flurouracil, or ingenol mebutate; 60 days
    • Glucocortico-steroids 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986920

Locations
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
Principal Investigator: Janet Dubois, MD Dermresearch, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01986920     History of Changes
Other Study ID Numbers: A-101-SEBK-201
Study First Received: November 6, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aclaris Therapeutics, Inc.:
SK

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014