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Trial record 5 of 14 for:    "Keratosis seborrheic"

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

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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.

Tracking Information
First Submitted Date  ICMJE November 6, 2013
First Posted Date  ICMJE November 19, 2013
Results First Submitted Date  ICMJE January 9, 2017
Results First Posted Date  ICMJE December 11, 2018
Last Update Posted Date December 11, 2018
Study Start Date  ICMJE October 22, 2013
Actual Primary Completion Date February 25, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Physician Lesion Assessment Scale [ Time Frame: Day 78 ]
Physician's subjective assessment of the condition of the lesion
Change History Complete list of historical versions of study NCT01986920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Subject's Self Assessment Scale [ Time Frame: Day 78 ]
Subjects assessment of the condition of their lesions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Seborrheic Keratosis (SK)
Intervention  ICMJE
  • Drug: A-101 25%
    Low Dose Concentration of A-101 applied to one of 4 Target Lesions
  • Drug: A-101 32.5%
    Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
  • Drug: A-101 40%
    High Dose Concentration A-101 applied to one of 4 Target Lesions
  • Drug: A-101 Vehicle
    Placebo applied to one of 4 Target Lesions
Study Arms  ICMJE
  • Active Comparator: A-101 25%
    Low dose group
    Intervention: Drug: A-101 25%
  • Active Comparator: A-101 32.5%
    Mid Dose Group
    Intervention: Drug: A-101 32.5%
  • Active Comparator: A-101 40%
    High Dose Group
    Intervention: Drug: A-101 40%
  • Placebo Comparator: A-101 Vehicle
    Placebo group
    Intervention: Drug: A-101 Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2018)
35
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2013)
36
Actual Study Completion Date  ICMJE February 25, 2014
Actual Primary Completion Date February 25, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986920
Other Study ID Numbers  ICMJE A-101-SEBK-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aclaris Therapeutics, Inc.
Study Sponsor  ICMJE Aclaris Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet Dubois, MD Derm Research, PLLC
PRS Account Aclaris Therapeutics, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP