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

Promius Pharma

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Comp01; Drug: Comp04; Drug: ACT01; Drug: Comp03; Drug: Comp02

Study type: Interventional

Funder types: Industry

Identifiers

NCT02126670

NP1401

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups, including a placebo group

ACT01 plus Comp01

Placebo Comparator group

Description:

ACT01 Cream in combination with Comp01 Cream, once daily, 29 days

Treatment:

Drug: ACT01

Drug: Comp01

ACT01 plus Comp02

Active Comparator group

Description:

ACT01 Cream in combination with Comp02 Cream, once daily, 29 days

Treatment:

Drug: ACT01

Drug: Comp02

ACT01 plus Comp03

Active Comparator group

Description:

ACT01 Cream in combination with Comp03 Cream, once daily, 29 days

Treatment:

Drug: ACT01

Drug: Comp03

ACT01 plus Comp04

Other group

Description:

ACT01 Cream in combination with Comp04 Cream, once daily, 29 days

Treatment:

Drug: ACT01

Drug: Comp04