ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis

Study Overview
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Brief Summary
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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.

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: ACT01
* Drug: Comp01
* Drug: Comp02
* Drug: Comp03
* Drug: Comp04


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ACT01 plus Comp01<br>ACT01 Cream in combination with Comp01 Cream, once daily, 29 days | Drug: ACT01<br> <br> Drug: Comp01<br> <br> |
| Active Comparator: ACT01 plus Comp02<br>ACT01 Cream in combination with Comp02 Cream, once daily, 29 days | Drug: ACT01<br> <br> Drug: Comp02<br> <br> |
| Active Comparator: ACT01 plus Comp03<br>ACT01 Cream in combination with Comp03 Cream, once daily, 29 days | Drug: ACT01<br> <br> Drug: Comp03<br> <br> |
| Other: ACT01 plus Comp04<br>ACT01 Cream in combination with Comp04 Cream, once daily, 29 days | Drug: ACT01<br> <br> Drug: Comp04<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success at End of Study Visit | Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions | up to Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation Score | Percentage of participants with moderate or severe overall irritation at end of treatment. | up to Day 57 |