Skip to main content
OpenTrials
Completed

NCT Number: NCT02126670

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Therapeutics Clinical Research, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACT01

Drug

Comp01

Drug

Comp02

Drug

Comp03

Drug

Comp04

Drug

Primary outcomes

  1. Treatment Success at End of Study Visit

    Time frame: up to Day 57

    Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

Secondary outcomes

  1. Irritation Score

    Time frame: up to Day 57

    Percentage of participants with moderate or severe overall irritation at end of treatment.

Sponsors and collaborators

Lead sponsor

Promius Pharma, LLC

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 30, 2014
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.