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

Completed · Phase 2

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT02126670

Run by

Promius Pharma, LLC

People needed

100

Starts

2014-04-01

Expected to finish

2014-09-01

Last updated by the study team

2016-02-22

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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