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Evaluation and comparison of the efficacy of Atorvastatin plus Zinc oxide versus zinc oxide in patients with moisture-associated skin damage (MASD)

Preparation and optimization of a formulation containing zinc and atorvastatin and evaluation of the effectiveness of the optimized formulation in the treatment and management of patients with moisture-associated skin damage (MASD); A clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120731010453N9
Enrollment
114
Registered
2025-11-25
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Moisture associated skin damage. Disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention 1: Intervention group: Optimized Atorvastatin 2% + Zinc Oxide Topical Emulgel
from time zero, three times a day until the intended treatment is healed
the treatment will be administered as follows: first, the area will be washed with water and a suitable shampoo, then the desired medication from each group will be applied to the surface of the area
from day zero, they will receive the intended treatment three times a day until recovery
the treatment will be administered as follows: first, the area will be washed with water and appropriate shampoo, then the intended medication for each group will be applied to the surface of the area

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients with skin damage (MASD) confirmed with severity IA and IIA Patients in the intensive care unit for at least 72 hours

Exclusion criteria

Exclusion criteria: The presence of clinical indicators or a positive culture confirms a bacterial or fungal infection. Death or discharge from the ICU earlier than 72 hours Patients with severe immune deficiency, pregnancy, and breastfeeding

Design outcomes

Primary

MeasureTime frame
Primary outcomes included improvement and reduction in the severity of skin redness based on the GLOBIAD-M criteria within the first 72 hours and until complete healing. Timepoint: In the study examining the effect of atorvastatin and zinc oxide on patients with MASD, patients will be examined daily before and during treatment. Method of measurement: Reduction in the size of redness and inflammation in the area and improvement in the condition of the lost skin based on the GLOBIAD-M criteria.

Secondary

MeasureTime frame
Secondary outcomes include the duration of complete recovery, as well as the number of treatment failures, including treatment lasting longer than 7 days (no significant improvement within the first 7 days) and the development of bacterial or fungal infections during treatment. Timepoint: In the study examining the effect of atorvastatin and zinc oxide on patients with MASD, patients will be evaluated daily before and during treatment. Method of measurement: The duration of recovery and the number of treatment sessions received will be recorded. The presence or absence of signs of infection such as colored discharge, discoloration of the area, vesicles, or blisters will also be examined.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Shafiekhani

Shiraz University of Medical Sciences

mojtabashafiekhani@gmail.com+98 71 3242 4255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026