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

NCT07759505 | Completed

• 1 other identifier: TeenDerm_2022-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acne-prone skin; azelaic acid; topical treatment; antibiotic; maintenance phase

Outcome Measures

Primary Outcomes (2)

• Percentage change from baseline in acne severity total lesion score

  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.

  Baseline, Day 42, Day 84, and Day 112

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

  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.

  Baseline, Day 42, Day 84, and Day 112

Secondary Outcomes (2)

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

  Baseline, Day 84, Day 112

• Tolerability of the product and patient satisfaction

  Baseline, Day 42,Day 84, and Day 112

Study Arms (3)

Teen Derm AZ: Azelaic acid cream with active ingredients (named α-AZ cream, Group 1)

α-AZ cream combined with oral antibiotic: Doxycycline (Group 2)

Cosmetic product applied once per day + Oral doxycycline 100 mg administered once daily as prescribed in routine clinical practice.

Topical antibiotic cream, Erythromycin / Zinc Acetate (Group 3)

Topical solution/cream combining erythromycin 40 mg/mL and zinc 12 mg/mL applied according to standard care.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population was drawn from patients received by the two study investigators

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ISISPHARMA: lead

Study Sites (1)

CMI Dermato-Venerologie, Hatami Kaleshtari Mohammad

Bucharest, 021391, Romania

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Afshin Dr Hatami, PhD

  CMI Dermato-Venerologie

  PRINCIPAL INVESTIGATOR

• Aura Dr Vladuti, PhD

  CMI Dermato-Venerologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: August 12, 2026
• Study Start: September 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)