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.
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Notify MeKey information
Conditions
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
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
Comp01
DrugComp02
DrugComp03
DrugComp04
DrugPrimary outcomes
-
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
-
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.
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