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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: ACT01; Drug: Comp01; Drug: Comp02; Drug: Comp03; Drug: Comp04

• Registration Number: NCT02126670
• Lead Sponsor: Promius Pharma, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-04-30
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-11-24
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Results First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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.
2. Age 30-85 years, inclusive.
3. 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

1. Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease.
2. Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism.
3. 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.
4. Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT01 plus Comp01	ACT01	ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01 plus Comp02	ACT01	ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01 plus Comp01	Comp01	ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01 plus Comp02	Comp02	ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01 plus Comp03	Comp03	ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01 plus Comp04	Comp04	ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01 plus Comp03	ACT01	ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01 plus Comp04	ACT01	ACT01 Cream in combination with Comp04 Cream, once daily, 29 days

Primary Outcome Measures

Name	Time	Method
Treatment Success at End of Study Visit	up to Day 57	Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

Secondary Outcome Measures

Name	Time	Method
Irritation Score	up to Day 57	Percentage of participants with moderate or severe overall irritation at end of treatment.

Trial Locations

Locations (4)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Dermatology Specialists Research, LLC; 🇺🇸 Louisville, Kentucky, United States

Dermatology Consulting Services; Zoe Diana Draelos, MD; 🇺🇸 High Point, North Carolina, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States