Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

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.

Layout table for study information
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

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




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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986920


Locations
Layout table for location information
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Janet Dubois, MD Derm Research, PLLC
  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:
Additional Information:
Layout table for additonal information
Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01986920    
Other Study ID Numbers: A-101-SEBK-201
First Posted: November 19, 2013    Key Record Dates
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:
Layout table for MeSH terms
Keratosis, Actinic
Keratosis
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms