Efficacy and safety of the Dermatological Soap with ozonized sunflower oil (AGO) and Cream with AGO in patients with Acne.

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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-ACNE

Scientific title:

Evaluation of the efficacy and safety of Dermatological Soap with ozonized sunflower oil and Cream with ozonized sunflower oil in patients with Acne.

Acronym of Scientific Title:

AGO-CREAM-ACNE

Secondary indentifying numbers:

AGO-ACNE-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:

Lidice

Last name:

Vazquez Sanchez

Medical 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:

+53-53798753

Email address:

lidice.vazquez@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:

Not applicable

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:

Acne

Intervention(s):

Group 1 (Experimental): Dermatological soap with AGO. The treatment will be applied topicaccy for 60 days. Acne lesions will be washed three times a day: in the morning, in the afternon and at night before going to bed. Group 2 (Control): Non-dermatological soap + Cream with AGO. The treatment will be applied topicaccy for 60 days. Acne lesions will be washed three times a day: in the morning, in the afternon and at night before going to bed. After each wash the cream will be applied to the lesions. Group 3 (Experimental): Dermatological soap with AGO + Cream with AGO. The treatment will be applied topicaccy for 60 days. Acne lesions will be washed three times a day: ni the morning, in the afternon and at night before going to bed. After each wash the cream will be applied to the lesions. 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):

Cure clinical (bsence of acneic skin lesions) or clinical improvement (significant reduction in acne skin lesions). Measurement time: At baseline and, 15, 30, 45 and 60 days of treatment.

Key secondary outcomes:

1. EASI Scale (Eczema Area and Severity Index). Measurement time: At baseline and, 15, 30, 45 and 60 days of treatment. 2. Quality of Life (Dermatology Life Quality Index (DLQI)): Measurement time: At baseline and, 15, 30, 45 and 60 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 of both sexes with 19 years old or older, who have acne-type skin lesions, and who agree to participate in the study by signing an informed consent

Exclusion criteria:

Patients with: • Skin lesions with added infection • Known hypersensitivity to the products to be used. • Other skin lesions already diagnosed. • Severe or grade 3 acne with 21 and 50 inflammatory lesions on one half of the face, or where there are numerous (between 40 and 100) papules or pustules with deep, infiltrating nodular lesions, the areas of lesions extend beyond the face, to the back and back

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:

Lidice

Last Name:

Vazquez Sánchez

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:

+53-53798753

Email :

lidice.vazquez@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:

31/01/2025

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:

RPCEC00000438

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 ozonized sunflower oil (AGO) and Cream with AGO in patients with Acne.

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