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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000437

Enrollment

Registered

2024-04-15

Start date

2024-09-02

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic dermatitis

Interventions

Group 1 (Experimental): Dermatological soap with AGO. The soap will use for bathing and cleaning the affected areas during 8 weeks. Group 2 (Control): Anti-inflammatory alcohol cream. The cream should

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 2. Mycological cure (negative mycological examination). Measurement time: At baseline and, Week 8 of treatment	—

Measure

Time frame

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 2. Mycological cure (negative mycological examination). Measurement time: At baseline and, Week 8 of treatment

—

Secondary

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

Countries

Cuba

Contacts

Public ContactMayilenis Gondres Mora

10 de Octubre Clinical Surgical Teaching Hospital

mayilenis@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026