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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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ACT01 plus Comp01

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

Group Type PLACEBO_COMPARATOR

ACT01

Intervention Type DRUG

Comp01

Intervention Type DRUG

ACT01 plus Comp02

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

Group Type ACTIVE_COMPARATOR

ACT01

Intervention Type DRUG

Comp02

Intervention Type DRUG

ACT01 plus Comp03

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

Group Type ACTIVE_COMPARATOR

ACT01

Intervention Type DRUG

Comp03

Intervention Type DRUG

ACT01 plus Comp04

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

Group Type OTHER

ACT01

Intervention Type DRUG

Comp04

Intervention Type DRUG

Interventions

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ACT01

Intervention Type DRUG

Comp01

Intervention Type DRUG

Comp02

Intervention Type DRUG

Comp03

Intervention Type DRUG

Comp04

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No