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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: ACT01; Drug: Comp01; Drug: Comp02; Drug: Comp03; Drug: Comp04

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research, LLC
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services; Zoe Diana Draelos, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Promius Pharma, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: NP1401