Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis

Summary

Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To prevent their development, a study is being conducted with oral isotretinoin and topical tretinoin to verify what drug is the most effective and has the best security profile for these patients. Along with these treatments, cryotherapy with liquid nitrogen and sunscreens will be part of the treatment. The study will have the duration of 10 months. In the first four months, the AKs will be counted and treated with cryotherapy (face and arms) and sunscreens FPS 60 will be used. After it, the patients will return (the AKs will be counted), a new session of cryotherapy will be performed and they will be randomized into two groups: one group using oral isotretinoin 10mg/day ( ISO: 30 patients) and the other one using tretinoin 0,05% cream (AR: 30 patients) applied on face and arms. Skin biopsies will be done for all 60 patients at the beginning of the treatment with retinoids (isotretinoin and tretinoin). After six months of treatment with retinoids, the study will be stopped, AKs will be counted again and skin biopsies will be done. Patients in the group ISO (oral isotretinoin) also have to make blood tests at the beginning, two months and after six months of the treatment. Clinical (AK counting), histological (improvement of parts of the skin) and immunohistochemical parameters will be evaluated to see what drug is more effective for prevention of AKs.

Conditions

• Actinic Keratosis

Interventions

DRUG

Oral isotretinoin

Oral isotretinoin - 10mg/day (one pill) after lunch for six months

DRUG

Tretinoin 0,05% cream

Topical tretinoin 0,05% cream - applied every other night in the face and forearms for six months

DRUG

Sunscreen FPS 60

Sunscreen FPS 60 applied on sun exposed areas every 3 hours daily

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Theraskin

  collaborator UNKNOWN

• Germed Pharma

  collaborator INDUSTRY

• Universidade Federal de Goias

  lead OTHER

Principal Investigators

• Edileia Bagatin, MD, PhD · Federal University of São Paulo UNIFESP

• Hélio A Miot, MD, PhD · University of Paulista State - Julio de Mesquita Filho, UNESP

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2014-04-30

Completion

2014-05-31

Countries

• Brazil

Study Locations