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).

A Double-blind Randomised Placebo-controlled Study of Topical Acitretin and Placebo for the Treatment of Facial Actinic Keratosis. Protocol Number: DP-001

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000333718

Acronym

ATAK

Enrollment

Registered

2013-03-26

Start date

2013-04-10

Completion date

2013-09-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Acitretin is a synthetic retinoid, structurally related to vitamin A. Its efficacy in psoriasis is well known as an oral treatment for severe psoriasis and disorders of keratinisation. A study of oral acitretin has shown benefit in renal transplant patients with Actinic Keratoses (AKs). AKs, also referred to as solar keratoses, are premalignant intra-epidermal skin lesions that usually arise in photodamaged skin areas. Acitretin is therefore expected to be of benefit in the treatment of AK. Topical acitretin may be associated with few, if any, systemic side effects whilst at the same time producing higher concentrations at the site of treatment compared with oral acitretin. The efficacy and safety of topical acitretin against a placebo control is to be assessed by a phase 2a study, involving approximately 75 participants in New Zealand.

Interventions

Participants are randomised to receive topical acitretin or placebo for 24 weeks. About 1g of Acitretin 0.25% w/w or 0.5% w/w will be applied once daily to the face. A three week follow-up for all participants occurs at the completion of the treatment phase. The dose concentration is determined by randomisation.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Healthy volunteers

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.

Outcome results