Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02260180
Other study ID # A-101-SEBK-203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2014
Est. completion date March 2015

Study information

Verified date November 2020
Source Aclaris Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.


Description:

The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Subject is at least 18 years of age 2. Subject has a Fitzpatrick skin type of 1-4 3. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis 4. Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face: - Have a clinically typical appearance - Be treatment naïve - Have a Physician's Lesion Assessment (PLA) of =2 (Section 6.1.2) - Have a longest axis that is =7mm and =15mm (Section 5.4) - Have a longest dimension perpendicular to the longest axis that is =7mm and =15mm (Section 5.4) - Have a thickness that is =2mm - Be a discrete lesion - Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present - Not be on the eyelids - Not be within 5mm of the orbital rim - Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair) - Not be in an intertriginous fold - Not be pedunculated. 5. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study 6. Subject is non-pregnant and non-lactating 7. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the target lesion or which exposes the subject to an unacceptable risk by study participation 8. Subject is willing and able to follow all study instructions and to attend all study visits 9. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF). Exclusion Criteria: 1. Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions 2. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat) 3. Subject has a current systemic malignancy 4. Subject has a history of keloid formation or hypertrophic scarring 5. Subject 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 6. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments: - LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy(PDT)) or other energy based therapy; 180 days - Retinoids; 28 days - Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days - Glucocortico-steroids or antibiotics; 14 days 7. Subject currently has or has had any of the following within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments : - A cutaneous malignancy; 180 days - Experienced a sunburn; 28 days - A pre-malignancy (e.g., actinic keratosis); currently - Body art (e.g., tattoos, piercing, etc.); currently - Excessive tan; currently 8. Subject has a history of sensitivity to any of the ingredients in the study medications 9. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) which, in the investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations 10. Subject 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


Intervention

Drug:
A-101
Topical Solution

Locations

Country Name City State
United States DermReseach, Inc. Austin Texas
United States Philadelphia Institute of Dermatology Fort Washington Pennsylvania
United States The Education & Research Foundation, Inc. Lynchburg Virginia
United States Oregon Medical Research Center Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8. The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. Day 106
Secondary Mean Change From Baseline PLA Score at Visit 8 A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome. Day 106
See also
  Status Clinical Trial Phase
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT01214564 - Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis Phase 2
Active, not recruiting NCT05136144 - Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis Phase 2
Recruiting NCT06108024 - A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis Phase 2
Completed NCT06046144 - Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors
Completed NCT03846531 - Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study N/A
Completed NCT03148691 - A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis Phase 2
Completed NCT03487588 - An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses Phase 4
Completed NCT02160626 - Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis Phase 2
Completed NCT00540566 - Optical Biopsy of Human Skin in Conjunction With Laser Treatment
Completed NCT01159860 - Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses? N/A
Terminated NCT04688749 - Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Completed NCT02667275 - A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis Phase 3
Completed NCT02667236 - A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis. Phase 3
Completed NCT02667288 - An Open-Label Safety Study of A-101 Solution Phase 3
Completed NCT05353374 - Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization N/A
Terminated NCT04249115 - Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study N/A