Study on the tolerance and efficiency of a dermo-cosmetic product for mild to moderate acne in combination or comparison to current treatments in Romania
| ISRCTN | ISRCTN70142596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70142596 |
| Secondary identifying numbers | 2022-01 |
- Submission date
- 01/02/2023
- Registration date
- 11/12/2023
- Last edited
- 04/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The aim of this study is to evaluate Teen Derm A.Z, a triple action care against persistent blemishes and marks and ultra-soothing that is applied on the face area.
Who can participate?
Patients with acne-prone skin. For groups 2 and 3 patients should begin an anti-acne treatment (zinc orally, antibiotic orally, contraceptive or hormonal treatment, topical retinoid, or a combination of these treatments).
What does the study involve?
First, the tolerance (cutaneous acceptability) of the treatment will be evaluated by clinical examination under dermatological control. Then, the effectiveness of the product in reducing acne lesions and marks (red and brown) will be assessed by the use of dermatological scoring and by comparing before and after pictures. Patient quality of life will be assessed and cosmetic acceptability and future use will be evaluated using a questionnaire.
What are the possible benefits and risks of participating?
The possible benefits are the improvement of acne severity.
Where is the study run from?
The study is run from 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 is the main contact?
Amélie Clément, aclement@isispharma.com
Contact information
Principal Investigator
CUI 21047847
Bulevardul Ferdinand I 12A
Bucarest
021391
Romania
| Phone | +40 (0)212520520 |
|---|---|
| hatamiafs@yahoo.com |
Principal Investigator
CUI 24519243, Strada Octav
Cocarascu nr 57
Bucarest
-
Romania
| Phone | +40 (0)723235601 |
|---|---|
| doctor.derma@yahoo.com |
Scientific
78 rue de la Villette
Lyon
69003
France
| Phone | +33 (0)4 28 00 04 00 |
|---|---|
| cmainzer@isispharma.com |
Public
78 rue de la Villette
Lyon
69003
France
| Phone | +33 (0)6 29 76 53 54 |
|---|---|
| aclement@isispharma.com |
Study information
| Study design | Open-label observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other therapist office |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparative efficacy and tolerability of a novel dermo-cosmetic cream with 15% azelaic acid for mild to moderate acne: a promising alternative to antibiotics |
| Study objectives | The product offers a good tolerance thanks to additional active ingredients and good efficacy on inflammatory lesions thanks to 15% azelaic acid. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study does not require ethics committee approval because it is conducted in private offices in Romania |
| Health condition(s) or problem(s) studied | Mild to moderate acne-prone skin |
| Intervention | The evaluated product is a cosmetic. Group 1: only the cosmetic product applied twice per day Group 2: cosmetic product applied once per day + concomitant treatment (according to the prescribing habits/needs of each patient) Group 3: usual treatment according to the prescribing habits/needs of each patient Evaluation of the tolerance (cutaneous acceptability) by clinical examination under dermatological control after 42 and 84 days of treatment Evaluation of the efficacy in reducing acne lesions and marks (red and brown) by use of dermatological scoring at baseline and after 42 and 84 days Evaluation of the global amelioration with before/after pictures at days 0, 42, and 84 Evaluation of the improvement of patient quality of life with the Cardiff Acne Disability Index (CADI) at days 0 and 84 Evaluation of the cosmetic acceptability and future use of the product by analysis of the subject’s answers to a subjective evaluation questionnaire on day 84 After 112 days, evaluation of the effects of stopping the treatment or product use after 1 month |
| Intervention type | Other |
| Primary outcome measure | Tolerance (cutaneous acceptability) by clinical examination under dermatological control at baseline, 42, 84, and 72 days |
| Secondary outcome measures | 1. Efficacy in reducing acne lesions and marks (red and brown) measured using dermatological scoring on days 0, 42, 84, and 112 2. Quality of life measured using the Cardiff Acne Disability Index (CADI) at days 0, 84 and 112 |
| Overall study start date | 26/09/2022 |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. Sex: female and/or male 2. Subject having given his/her informed written consent or parental authorization 3. Subject willing to adhere to the protocol and study procedures Specific criteria: 1. Healthy subject with acne-prone skin: grade 2 or 3 (Global Acne Evaluation [GEA] scale) and with at least 10 inflammatory lesions 2. Group 2 and 3: Beginning an anti-acne treatment (zinc orally, antibiotic orally, contraceptive or hormonal treatment, topical retinoid or a combination) |
| Key exclusion criteria | 1. Excluding treatment: 1.1. Epiduo® or combination of benzoyl peroxide (BPO) + Adapalene 1.2. Oral isotretinoin 1.3. Chronically used anti-inflammatory drugs 2. Subject manipulating his/her acneic lesions 3. Any change in hormonal treatment (including contraceptives) during the three previous months of the study 4. Cutaneous pathology on the study zone (eczema, etc) 5. Excessive exposure to sunlight or UV rays within the previous month 6. Subject enrolled in another clinical trial during the study period |
| Date of first enrolment | 01/10/2022 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Romania
Study participating centres
Bucarest
021391
Romania
Bucarest
-
Romania
Sponsor information
Industry
78 rue de la Villette
Lyon
69003
France
| Phone | +33 (0)4 28 00 04 00 |
|---|---|
| contact@isispharma.com | |
| Website | https://www.isispharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 04/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Individual participant data are irretrievably and definitively anonymized, without the possibility of identification of the participant concerned, by the Investigator according to the standards in force guaranteeing complete confidentiality, prior to any transmission, display, or transfer to anyone. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 04/07/2024 | No | No | ||
| Results article | 02/11/2024 | 04/11/2024 | Yes | No |
Additional files
Editorial Notes
04/11/2024: Publication reference added.
04/07/2024: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. The scientific title was changed from "Clinical observational study on the evaluation of the efficacy and the cutaneous tolerance of a cosmetic product on the acne-prone Romanian population" to "Comparative efficacy and tolerability of a novel dermo-cosmetic cream with 15% azelaic acid for mild to moderate acne: a promising alternative to antibiotics".
3. The total final enrolment was added.
4. The intention to publish date was changed from 01/10/2023 to 04/07/2024.
28/05/2024: A scientific contact was changed.
15/02/2023: Trial's existence confirmed by ISISPHARMA.
