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Efficacy and Tolerability Evaluation of a Novel Dermo-cosmetic Product for Mild-to-moderate Acne

NCT07759505 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-08-12

No results posted yet for this study

Summary

The goal of this non-interventional, observational study is to evaluate the real-world efficacy and tolerance of a novel dermocosmetic cream containing 15% Azelaic acid and a complex of active ingredients (α-AZ cream) in patients with mild-to-moderate acne treated in routine clinical practice.

The main questions addressed are:

* Does the product show good clinical efficacy on acne and inflammatory lesions in standard practice?
* Does the product offer good cutaneous tolerance during routine use?

Patients are observed across three routine care cohorts according to their prescribed/recommended regimen: α-AZ cream alone (Group 1), α-AZ cream combined with an oral acne treatment (Group 2), or a topical acne treatment (Group 3), over a period of 84 days. The study observes and compares real-world outcomes and tolerance across these standard care management approaches without imposing any protocol-driven treatment allocation.

Researchers will compare the new dermocosmetic cream with group 2 and group 3 to see if the study product shows an equivalent or a better tolerance/efficiency than the drug treatment.

Conditions

  • Acne Vulgaris

Sponsors & Collaborators

  • ISISPHARMA

    lead INDUSTRY

Principal Investigators

  • Afshin Dr Hatami, PhD · CMI Dermato-Venerologie

  • Aura Dr Vladuti, PhD · CMI Dermato-Venerologie

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759505 on ClinicalTrials.gov