An observational study in Acne Vulgaris, sponsored by ISISPHARMA. Completed at 1 site in Romania. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by ISISPHARMA · Observational
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:
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.
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).
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 90 is close to the median of 88 across 95 observational studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →ISISPHARMA is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The population was drawn from patients received by the two study investigators
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Excluding treatment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cosmetic product applied once per day + Oral doxycycline 100 mg administered once daily as prescribed in routine clinical practice.
Topical solution/cream combining erythromycin 40 mg/mL and zinc 12 mg/mL applied according to standard care.
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.
Time frame: 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.
Time frame: Baseline, Day 42, Day 84, and Day 112
Change from baseline in Quality of Life assessed by the Cardiff Acne Disability Index (CADI)
Subject-reported quality of life evaluated using the validated CADI questionnaire score.
Time frame: Baseline, Day 84, Day 112
Tolerability of the product and patient satisfaction
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.
Time frame: Baseline, Day 42,Day 84, and Day 112
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Jun 2023, 9 months.
Of 22 industry-sponsored observational studies under Acne Vulgaris, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 9 months is above that.
Counting every sponsor, half of 37 studies reached it within 10 months; a quarter within 3 and three quarters within 13.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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