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

Actinic Keratosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126670
• Other study ID #: NP1401
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2014
• Last updated: January 25, 2016
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2016
• Source: Promius Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• ACT01

• Comp01

• Comp02

• Comp03

• Comp04

Locations

Country	Name	City	State
United States	Dermatology Consulting Services; Zoe Diana Draelos, MD	High Point	North Carolina
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Promius Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Irritation Score	Percentage of participants with moderate or severe overall irritation at end of treatment.	up to Day 57	Yes