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

Not Applicable

• Conditions: Chronic dermatitis

• Registration Number: RPCEC00000437
• Lead Sponsor: ational Center for Scientific Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Last Update Posted: 19 August 2024
• Study Completion: 2025-03-27
• Results First Posted: 2025-05-12

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>2. Mycological cure (negative mycological examination). Measurement time: At baseline and, Week 8 of treatment

Secondary Outcome Measures

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