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Completed

NCT Number: NCT07759505

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CMI Dermato-Venerologie, Hatami Kaleshtari Mohammad

Bucharest, 021391, Romania

About this study

Background and study aims:

Acne vulgaris is a prevalent skin condition, especially among teenagers and young adults. Traditional treatments, including topical retinoids and antibiotics, often lead to side effects that reduce adherence and effectiveness.The study aimed to evaluate the efficacy and tolerability of a novel dermo-cosmetic cream containing 15% azelaic acid in alleviating acne burden in patients with mild-to-moderate acne.

Study Nature and Non-Intervention:

This is a purely observational study. Treatment choices (including α-AZ cream and/or standard anti-acne medications) are made solely at the discretion of the treating physician in accordance with routine medical practice, independently of and prior to patient inclusion in the study. Participation in the study does not alter the patient's therapeutic care, and no protocol-mandated interventions or additional invasive procedures are imposed.

Who can participate? Patients aged 12 years and older presenting with mild-to-moderate acne managed in routine clinical practice.

What does the study involve? Observational evaluations are conducted during routine clinical visits (baseline and follow-up visits) to record acne severity (comedones, papules, pustules, and nodules) and total number of inflammatory lesions (red and brown marks). Treating physicians record routine product tolerability, and subjects complete a Quality of Life (QoL) questionnaire during their standard care follow-up.

What are the possible benefits and risks of participating? Participants receive standard care for their condition, which aims to improve acne severity. Since treatment is prescribed within standard clinical practice, risks do not differ from normal routine care.

Where is the study run from? The study is conducted in two private dermatologists' offices in Romania.

When is the study starting and how long is it expected to run for? September 2022 to September 2023.

Who is funding the study? ISISPHARMA (France).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sex: female and/or male
  • Subject having given his/her informed written consent or parental authorization
  • Subject willing to adhere to the protocol and study procedures
  • Healthy subject with acne-prone skin: grade 2 or 3 (Global Acne Evaluation [GEA] scale).

Exclusion criteria

  • Excluding treatment:
  • Epiduo® or combination of benzoyl peroxide (BPO) + Adapalene
  • Oral isotretinoin
  • Chronically used anti-inflammatory drugs
  • Subject manipulating his/her acneic lesions
  • Any change in hormonal treatment (including contraceptives) during the three previous months of the study
  • Cutaneous pathology on the study zone (eczema, etc)
  • Excessive exposure to sunlight or UV rays within the previous month
  • Subject enrolled in another clinical trial during the study period

Treatment and study plan

Primary outcomes

  1. Percentage change from baseline in acne severity total lesion score

    Time frame: Baseline, Day 42, Day 84, and Day 112

    Acne severity evaluated by counting open/closed comedones (R), papules/pustules (Is), and nodules (Ip) on a scale from 0 (clear) to 5 (severe). Total score is calculated as R + Ip + Is, and relative change (%) from baseline is reported.

  2. Percentage change from baseline in Post-Inflammatory Hyperpigmentation (PIH) score

    Time frame: Baseline, Day 42, Day 84, and Day 112

    Evaluation of post-hyper-pigmentation inflammatory marks categorized as none (≤2), mild (3-4), moderate (5-6), or severe (7-8). Relative change (%) from baseline is reported.

Secondary outcomes

  1. Change from baseline in Quality of Life assessed by the Cardiff Acne Disability Index (CADI)

    Time frame: Baseline, Day 84, Day 112

    Subject-reported quality of life evaluated using the validated CADI questionnaire score.

  2. Tolerability of the product and patient satisfaction

    Time frame: Baseline, Day 42,Day 84, and Day 112

    Treatment tolerance and patient's assessment:

    Investigators evaluated patient tolerability by documenting erythema, edema, dryness, desquamation, roughness.Subjects completed the questionnaire on the effectiveness and cosmetic acceptability of the product.

Sponsors and collaborators

Lead sponsor

ISISPHARMA

Industry

Registry information

Official study title

A Pilot Study on the Comparative Efficacy and Tolerability of a Novel Dermo-cosmetic Cream With 15% Azelaic Acid for Mild to Moderate Acne: A New Approach to Acne Treatment

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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