Evaluation of the antiinflammatory effect of the Vimang® cream in patients with Dermatitis chronic disease.

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:

Not applicable

Scientific title:

Evaluation of the antiinflammatory effect of the Vimang® cream in patients with Dermatitis chronic disease.

Acronym of Scientific Title:

Not applicable

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Ministry of Public Health Ministry of Science, Technology and Environment

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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

13/02/2006

Reference number:

N-03-148-M02

Principal investigator

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

First name:

Tania

Last name:

Pérez

Medical Specialty :

1st Degree Specialist in Dermatology

Affiliation:

Dr. Carlos J. Finlay Hospital

Postal address:

Avenida 31 y 114

City:

La Habana

País:

Cuba

Zip Code:

11400

Telephone:

+53-72743000

Email address:

email@not.entered [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

Research ethics committees:

Ethics Committee of the Dr. Carlos J. Finlay Hospital Date: October 08, 2004

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

18/03/2007

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:

Dermatitis Chronic disease

Health condition(s) code:

Dermatitis

Skin Diseases

Intervention(s):

They were formed two study groups. The study group received topical application with cream Vimang® 1.2%, three times to day during 6 weeks. The control group received topical application with the placebo cream in same dose and frequency.

Intervention code:

Mangifera indica

Ointments

Antioxidants

Anti-Inflammatory Agents

Administration, Cutaneous

Placebos

Intervention keyword:

Vimang®

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):

Clinical evaluation through the method DASI (Dermatitis Assay Score Index). DASI will be evaluated in the first consultation and to the 6 weeks.

Key secondary outcomes:

It will be evaluated by interrogation and physical exam in weekly consultations during 6 weeks the presence of adverse effects: Pruritus Pain Ardor Blush Inflammation

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years old

Maximum age:

60 years old

Inclusion criteria:

1. Pacients that sign the Informed Consent. 2. Patients with clinical and histological diagnosis of Dermatitis in chronic phase. The histologic study must be made at least 1 year before the inclusion. 3. Patients with extension of disease between the 2 and 30% of the affected corporal surface of agreement with the result obtained with the pattern of localization of the lesions. 4. Patients that could be receive ambulatory treatment.

Exclusion criteria:

1. Pregnancy, puerperal time or nursing. 2. Patients that have received another specific therapy for the Dermatitis during 10 previous days to the entrance in the study. 3. Patients with Dermatitis in acute phase or subacute. 4. Patients with steroid treatmemt. 5. Patients with illness chronic associate in acute phase(diabetes mellitus, renal chronic failure, hypertension, heart disease, severe psychiatric dysfunction or cancer) 6. Patients with acute severe infectious or in convalescence. 7. Patients with autoinmune diseases of any type. 8. The patient's negative to carry out protocolized studies. 9. Patients that are not corresponded the clinical study with the histological 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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

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:

Mariela

Middle Name:

Margarita

Last Name:

Guevara-Garcia

Specialty:

1st Degree Specialist in Pharmacology

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St. Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537)271 5067

Email :

marielaguevara@infomed.sld.cu [2]

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:

Mariela

Middle Name:

Margarita

Last Name:

Guevara-Garcia

Specialty:

1st Degree Specialist in Pharmacology

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

marielaguevara@infomed.sld.cu [2]

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:

RPCEC00000001

Date of Registration in Primary Registry:

2009-02-12

Record Verification Date:

2017/01/20

Next update date:

2018/01/20

Link to the spanish version:

Click here [3]