Efficacy and safety of the Dermatological Soap with ozonated sunflower oil (AGO), or with sulfur, or with sulfur+AGO and Cream with AGO in patients with Scabies.

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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:

AGO-ESC

Scientific title:

Evaluation of the efficacy and safety of Dermatological Soap with AGO, or with sulfur, or with sulfur+AGO and Cream with AGO in patients with Scabies.

Acronym of Scientific Title:

AGO-ESCABIOSIS

Secondary indentifying numbers:

AGO-ESC-01

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

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:

Thuyen

Last name:

Fong Fernandez

Medical Specialty :

Second 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

País:

Cuba

Zip Code:

10300

Telephone:

+53-52655476

Email address:

thuyen.fong@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, Thuyen Fong Fernandez, MD. Second Degree specialist in Dermatology

Havana, "28 de Enero" Elderly House, Thuyen Fong Fernandez, MD. Second 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:

Scabies

Intervention(s):

Group 1 (Experimental): Dermatological soap with AGO + Cream with AGO. The soap will be used for daily bathing in the afternon and then applyng the cream, topically, from the neck down, scalp and ears for 21 days. Group 2 (Control): Dermatological soap with sulfur + Cream with AGO. The soap will be used for daily bathing in the afternon and then applyng the cream, topically, from the neck down, scalp and ears for 21 days. Group 3 (Experimental): Dermatological soap with sulfur-AGO + Cream with AGO. The soap will be used for daily bathing in the afternon and then applyng the cream, topically, from the neck down, scalp and ears for 21 days. AGO: Ozonized sunflower oil

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 (absence of itching and skin lesions ) or clinical improvement (improvement of itching and skin lesions). Measurement time: 7, 14 and 21 days of treatment. 2. Negativization of Dermatoscopy (Positive, Negative). Measurement time: 21 days of treatment.

Key secondary outcomes:

1. EASI Scale (Eczema Area and Severity Index). Measurement time: At baseline and, 7, 14 and 21 days of treatment. 2. VAS Scale (Visual analogical scale). Measurement time: At baseline and, 7, 14 and 21 days of treatment. 3. Quality of Life Questionnaire (EuroQol). Measurement time: At baseline and, 7, 14 and 21 days 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 confirmed scabies, of both sexes, 19 years or older, who present itching mainly at night and the presence of skin lesions, who agree to participate in the study after signing their informed consent.

Exclusion criteria:

Patients with: 1. Skin lesions with added infection 2. Known hypersensitivity to the products to be used 3. Other skin lesions already diagnosed 4. Moderate-severe cognitive disorders

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:

75

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:

Thuyen

Last Name:

Fong Fernandez

Specialty:

Second 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

País:

Cuba

Zip Code:

10300

Telephone:

+53-52655476

Email :

thuyen.fong@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:

Dr. in Pharmaceutical Sciences

Affiliation:

National Centre for Scientific Research (CNIC)

Postal Address:

25 avenue and 158 stree, Cubanacan, Playa

City:

Havana

País:

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

Correo electrónico:

manuel.hernandez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

25/11/2024

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:

RPCEC00000439

Date of Registration in Primary Registry:

16/04/2024

Record Verification Date:

2024/04/16

Next update date:

2025/04/16

Link to the spanish version:

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Proceso de Registro

Efficacy and safety of the Dermatological Soap with ozonated sunflower oil (AGO), or with sulfur, or with sulfur+AGO and Cream with AGO in patients with Scabies.

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