Back to resultsACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACT01
Comp01
Comp02
Comp03
Comp04
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility Criteria
Inclusion Criteria:
- Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter.
- Age 30-85 years, inclusive.
- Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Exclusion Criteria:
- Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
- Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism.
- Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit.
- Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.
Sites / Locations
- Therapeutics Clinical Research
- Dermatology Specialists Research, LLC
- Dermatology Consulting Services; Zoe Diana Draelos, MD
- Tennessee Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Other
Arm Label
ACT01 plus Comp01
ACT01 plus Comp02
ACT01 plus Comp03
ACT01 plus Comp04
Arm Description
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
Outcomes
Primary Outcome Measures
Treatment Success at End of Study Visit
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
Secondary Outcome Measures
Irritation Score
Percentage of participants with moderate or severe overall irritation at end of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02126670
Brief Title
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promius Pharma, LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACT01 plus Comp01
Arm Type
Placebo Comparator
Arm Description
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
Arm Title
ACT01 plus Comp02
Arm Type
Active Comparator
Arm Description
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
Arm Title
ACT01 plus Comp03
Arm Type
Active Comparator
Arm Description
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
Arm Title
ACT01 plus Comp04
Arm Type
Other
Arm Description
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
Intervention Type
Drug
Intervention Name(s)
ACT01
Intervention Type
Drug
Intervention Name(s)
Comp01
Intervention Type
Drug
Intervention Name(s)
Comp02
Intervention Type
Drug
Intervention Name(s)
Comp03
Intervention Type
Drug
Intervention Name(s)
Comp04
Primary Outcome Measure Information:
Title
Treatment Success at End of Study Visit
Description
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
Time Frame
up to Day 57
Secondary Outcome Measure Information:
Title
Irritation Score
Description
Percentage of participants with moderate or severe overall irritation at end of treatment.
Time Frame
up to Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter.
Age 30-85 years, inclusive.
Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Exclusion Criteria:
Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism.
Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit.
Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Dermatology Consulting Services; Zoe Diana Draelos, MD
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
12. IPD Sharing Statement
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ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
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