Acne VulgarisNCT07759505
Efficacy and Tolerability Evaluation of a Novel Dermo-cosmetic Product for Mild-to-moderate Acne
An observational study of Acne Vulgaris, run by ISISPHARMA at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteRomania
- Study dates
- 23 Sep 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population was drawn from patients received by the two study investigators
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Romania1 site
CMI Dermato-Venerologie, Hatami Kaleshtari Mohammad
Bucharest, 021391
About this study
Official 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
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:
Read more
- 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.
Read the detailed description
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).
- Conditions
- Acne Vulgaris
- Keywords
- Acne-prone skin, azelaic acid, topical treatment, antibiotic, maintenance phase
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Teen Derm AZ: Azelaic acid cream with active ingredients (named α-AZ cream, Group 1) | Not described | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Subject-reported quality of life evaluated using the validated CADI questionnaire score.
Measured: 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.
Measured: Baseline, Day 42,Day 84, and Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start23 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISISPHARMA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Afshin Dr Hatami, PhD, Principal investigator, CMI Dermato-VenerologieAura Dr Vladuti, PhD, Principal investigator, CMI Dermato-Venerologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759505
- Sponsor's protocol ID
- TeenDerm_2022-01
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07759505
- Acronym / sponsor ID
- TeenDerm_2022-01
- Conditions
- Acne Vulgaris
- Keywords
- Acne-prone skin, azelaic acid, topical treatment, antibiotic, maintenance phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- ISISPHARMAIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population was drawn from patients received by the two study investigators
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- Excluding treatment:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Change from baseline in Quality of Life assessed by the Cardiff Acne Disability Index (CADI)
Time frame: Baseline, Day 84, Day 112
Tolerability of the product and patient satisfaction
Time frame: Baseline, Day 42,Day 84, and Day 112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afshin Dr Hatami, PhD principal investigator
CMI Dermato-Venerologie
Aura Dr Vladuti, PhD principal investigator
CMI Dermato-Venerologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by ISISPHARMA at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in acne severity total lesion score (time frame: Baseline, Day 42, Day 84, and Day 112). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.