Efficacy and safety of the Dermatological Soap with ozonated sunflower oil (AGO) and Anti-inflammatory Alcohol Cream in patients with chronic Dermatitis.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

CREAM-CD

Scientific title:

Evaluation of the efficacy and safety of Dermatological Soap with ozonated sunflower oil (AGO) and Anti-inflammatory Alcohol Cream in patients with chronic Dermatitis.

Acronym of Scientific Title:

Cream - Chronic Dermatitis

Secondary indentifying numbers:

CREMA-DC-01

Issuing authority of the secondary identifying numbers:

National Center for Scientific Research

Source(s) of monetary or material support:

Ministry of Science, Technology and Enviroment (CITMA)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Mayilenis

Last name:

Gondres Mora

Medical Specialty :

First Degree Specialist in Dermatology

Affiliation:

10 de Octubre Clinical Surgical Teaching Hospital

Postal address:

10 de Otubre No 130/ Agua Dulce y Serafines, Cerro

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-54804696

Email address:

mayilenis@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, "General Peraza" Elderly House, Mayilenis Gondres Mora, MD. First Degree Specialist in Dermatology

Havana, "28 de Enero" Elderly House, Mayilenis Gondres Mora, MD. First Degree Specialist in Dermatology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

02/09/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic dermatitis

Intervention(s):

Group 1 (Experimental): Dermatological soap with AGO. The soap will use for bathing and cleaning the affected areas during 8 weeks. Group 2 (Control): Anti-inflammatory alcohol cream. The cream should be applied in a thin layer to the affected areas twice a day, preferably in the morning and at night after washing the lesions with the products you usually use the cream will use for 8 weeks. Group 3 (Experimental): Dermatological soap with AGO - anti-inflammatory alcohol cream. The soap will use for bathing and cleaning the affected areas. The cream should be applied in a thin layer to the affected areas twice a day, preferably in the morning and evening, after washing the lesions with the dermatological soap. The soap and the cream will use for 8 weeks.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Cure clinical (elimination of itching and absence of lesions typical of chronic dermatitis. or clinical improvement and mycological negativization) or Clinical improvement (Reduction in pruritus and improvement in lesions). Measurement time: At baseline and, Week 2, 4, 6 and 8 of treatment 2. Mycological cure (negative mycological examination). Measurement time: At baseline and, Week 8 of treatment

Key secondary outcomes:

1. EASI Scale (Eczema Area and Severity Index). Measurement time: At baseline and, Week 2, 4, 6 and 8 of treatment 2. VAS Scale (Visual Analogue Scale adapted to Pruritus). Measurement time: At baseline and, Week 2, 4, 6 and 8 of treatment 3. Life Quality Index Score of patients with Chronic Dermatitis (DLQI). Measurement time: At baseline and, Week 2, 4, 6 and 8 of treatment

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

Patients with 19 years old or older, of both sexes, who have signed their informed consent to participate in the study, with a clinical diagnosis of chronic dermatitis, treatment-naïve or with more than five days without specific topical or systemic treatment.

Exclusion criteria:

1. Decompensated diabetes mellitus (fasting glucose > 7 mmol/L). 2. Skin neoplasms diagnosed in the area to be treated. 3. Associated septic states that require immediate treatment. 4. History of liver disease or chronic kidney disease. 5. Other decompensated chronic diseases. 6. Pregnancy. 7. Concomitant use of corticosteroids, cytostatics or immunosuppressants and antibiotics. 8. Moderate-severe cognitive disorders. 9. Usual medical history of allergy to medications or any other special condition that, in the doctor's opinion, puts your health and life at risk during the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

90

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayilenis

Last Name:

Gondres Mora

Specialty:

First Degree Specialist in Dermatology

Affiliation:

10 de Octubre Clinical Surgical Teaching Hospital

Postal Address:

10 de Octubre No 130 /Agua Dulce y Serafines, Cerro

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-54804696

Email :

mayilenis@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Doctor in Pharmaceutical Sciences

Affiliation:

National Center for Scientific Research

Postal Address:

25 Avenue and 158 Street, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

10 de Octubre Clinical Surgical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/11/2023

Postal address of Ethic Committee :

10 de Octubre No. 130 e/ Agua Dulce y Serafines. Cerro, ZC:10300, La Habana. Cuba

Telephone:

+53-78252292

Email:

manuel.hernandez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

27/01/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000437

Date of Registration in Primary Registry:

15/04/2024

Record Verification Date:

2024/04/15

Next update date:

2025/04/15

Link to the spanish version:

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Efficacy and safety of the Dermatological Soap with ozonated sunflower oil (AGO) and Anti-inflammatory Alcohol Cream in patients with chronic Dermatitis.

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