Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Tretinoin

Sunscreening Agents

Isotretinoin

Keratolytic Agents

Protective Agents

Radiation-Protective Agents

Oral isotretinoin 10mg/day for 6 months The dose could be reduced if there were any significant laboratory alterations or clinical adverse events, along with sunscreen FPS 60 every 3 hours during the day.

An every other night application of tretinoin 0,05% cream in the face and forearms for 6 months, along with sunscreen FPS 60 every 3 hours during the day.

If there were any clinical adverse events the drug could be reduced to twice a week.

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

Oral isotretinoin

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

Tretinoin 0,05% cream

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

Sunscreen FPS 60

Edileia Bagatin, MD, PhD

Hélio A Miot, MD, PhD

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.

This study is a randomized controlled trial with 60 men and women (already in menopause for at least one year), aged 50-75 years. At the beginning, the number of actinic keratosis (AKs) of face and forearms will be counted and treated with cryotherapy with liquid nitrogen (LN).The patients will be randomized in two groups: one receiving oral isotretinoin 10mg/day every day and other receiving tretinoin 0,05% cream applied in the face and arms every other night, for six months. Along with these treatments, patients will use sunscreens FPS 60 with UVA and UVB protection. The inclusion criteria will be the presence of at least 10 and maximum 40 AKs (visible or palpable). Skin biopsies will be performed twice (before and after treatment with retinoids) for all patients, in the left forearm at a standardized site. Histological and immunohistochemical with blinded- evaluator analysis will be done. The main objective of the study is to evaluate clinical, histological and immunohistochemical effects of retinoids for AK prevention on face and forearms of immunocompetent individuals. Efficacy evaluation will be measured by improving clinical (AK counting before and after treatments), histopathological (Hematoxilin-eosin and Verhoeff staining) and immunohistochemical parameters (markers for carcinogenesis - p53 protein, Bcl-2 and Bax). The secondary objective is evaluate the tolerability and safety of the drugs and their impact in quality of life. The safety analysis will be related to adverse events of the two drugs and the blood tests will be performed in the ISO group patients. Indirectly, by decreasing the number of AKs and the expression of cutaneous carcinogenesis markers, a decrease in the risk of squamous cell carcinoma could be infered . This principle is used by many drugs called chemoprophylactic drugs, and the retinoids are considered in this group.

Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis

Low Dose Oral Isotretinoin Versus Topical Tretinoin for Prevention of Actinic Keratosis in Immunocompetent Patients: a Randomized, Comparative Trial

The Dermatology Life Quality Index (DLQI) questionnaire is performed for every patient at the time frames specified. With the reduction of actinic keratosis and use of retinoids it is expected for retinoids to reduce points of the questionnaire.

The clinical adverse events with tretinoin 0,05% cream are: erythema, burning sensation, desquamation, irritation The clinical adverse events with oral isotretinoin are: cheilitis, xerophthalmia, xerostomia, dry skin, epistaxis, and other mucocutaneous side effects

At day 120 (4 months) the patients of isotretinoin group (ISO) were submitted to laboratory tests: complete blood count, alanine and aspartate aminotransferase, fasting plasma glucose test and lipid profile tests.

At day 180 (6 months) the laboratory tests were repeated, except fasting plasma glucose test At day 300 (10 months) the laboratory tests were asked and repeated after 1 month, except fasting plasma glucose test

The actinic keratosis (AKs) will be counted by the same evaluator twice, in different moments at the same day, at the beginning of the study, after 4 months and at the end (10 months)

Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300) and stained with hematoxilin-eosin (HE)

Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to reduce the expression of this marker of carcinogenesis.

Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to increase the expression of this marker of carcinogenesis.

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Theraskin

Germed Pharma

Universidade Federal de Goias

Assistant Professor, MD, MsC

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Use of existing validated program "vivre avec le soleil"

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association

Use of existing validated program "vivre avec le soleil" associated with prevention awareness program of MISOLRE association and with the distribution of caps, sunscreens and sunglasses

Training of an ambassador class by a field coordinator Dissemination of the information by the ambassador class to the other classes of the school drawn by lot Transmission of an information document to parents on photoprotection to make them aware of the actions to adopt

MISOLRE prevention program on sun risks

Program is delivered directly by the teachers through pedagogical books : 10 workshops over a period of 3 months

"Vivre avec le Soleil" prevention program on sun risks

Distribution of sunscreen, caps and sunglasses

Sun protection equipment

Antoine BERTOLOTTI

Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. The country with the highest age-standardized incidence rate is Australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. Since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. In the French overseas department of Reunion Island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (UV) index is very high - equivalent to that in Australia. The age-standardized incidence rate of melanoma Reunion Island increased fourfold between 1995 and 2015. In 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes I-III, compared to 13.5 in metropolitan France.

Over the course of a lifetime, 80% of exposure to UV radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. In spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. Similar quantitative data have been reported for Reunion Island by the local association MiSolRé (Mission Soleil Réunion), which has been running sun safety campaigns in elementary schools since 2017. However, methodological limitations compromise the validity and extrapolation of the results. And the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? Community reinforcement through training activities involving peers? Improving access to prevention? Thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "Vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. The aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in Reunion Island, on the pupils' knowledge of sun prevention.

The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

self questionnaire completed by the students. Comparison of pourcentage of good response to knowledge questionnaire in the 4 arms. No minimum or maximum score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis	NCT02278861	Actinic Keratos...	Oral isotretino... Tretinoin 0,05%... Sunscreen FPS 6...	50 Years - 75 Years	Universidade Federal de Goias
The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region	NCT05367180	Melanoma	MISOLRE prevent... "Vivre avec le ... Sun protection ...	7 Years - 11 Years	Centre Hospitalier Universitaire de la Réunion
The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region	NCT05367180	Melanoma	MISOLRE prevent... "Vivre avec le ... Sun protection ...	7 Years - 11 Years	Centre Hospitalier Universitaire de la Réunion
Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis	NCT02278861	Actinic Keratos...	Oral isotretino... Tretinoin 0,05%... Sunscreen FPS 6...	50 Years - 75 Years	Universidade Federal de Goias

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