Topical Acitretin for the Treatment of rough scaly spots of sun-damaged skin or premalignant condition of thick, scaly, or crusty patches of sun-damaged skin (Facial Actinic Keratosis).

Completed

• Conditions: Facial actinic keratoses; Skin - Dermatological conditions

• Registration Number: ACTRN12613000333718
• Lead Sponsor: Douglas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

At least 3, to a maximum of 25, visible or palpable AK lesions on the face determined by clinical diagnosis.

- Males, or postmenopausal/surgically sterile females.

- Willing and able to comply with the protocol and study requirements.

Exclusion Criteria

- Atypical AK on the face.

- Diagnosis of SBCC on the face.

- Treatment with oral acitretin.

- Treatment with 5FU, imiquimod, diclofenac, PEP005 or topical retinoids on the face.

- Treatment with a dermatological procedure or surgery on the face.

- Other potentially confounding skin disorders on the face.

- Females of child bearing potential.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the partial clearance rates for each treatment group. The proportion of participants with 75 % or greater reduction of the number of AK Lesions on the face at the end of treatment compared to baseline. Measured by clinical assessment by the Principal Investigator or Sub-Investigator (lesion count).[24 weeks]

Secondary Outcome Measures

Name	Time	Method
Comparison of the total number of all visible or palpable AKs on the entire face at the end of treatment (i.e. those present at baseline and any new lesions) for each treatment group, measured by clinical assessment by the Principal Investigator or Sub-Investigator (lesion count).[24 weeks];Comparison of the change in the EIS Score for the entire face by treatment group compared with baseline.[Weeks 8, 16, and 24/end of treatment]