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

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

By CPN
Created 04/03/2024 - 2:42pm
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
Primary sponsor: 
National Center for Scientific Research
Secondary sponsor: 
Not applicable
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 [1]
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 [1]
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 [2]
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan: 
No
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
Date of available results: 
30/04/2025
Date of first publication: 
30/06/2025
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: 

Click here [3]

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Source URL (retrieved on 21/05/2024 - 1:46am): https://rpcec.sld.cu/en/trials/RPCEC00000438-En

Links:
[1] mailto:lidice.vazquez@infomed.sld.cu
[2] mailto:julio.fernandez@cnic.cu
[3] https://rpcec.sld.cu/ensayos/RPCEC00000438-Sp