A clinical study on the effects of ω-3 fatty acids on moderate and severe acne and gut microbiota
| ISRCTN | ISRCTN31758284 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31758284 |
| Secondary identifying numbers | Version 1.0 |
- Submission date
- 30/08/2022
- Registration date
- 07/09/2022
- Last edited
- 03/01/2024
- 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
Acne, an inflammatory disease of the follicles of the skin, may induce scars which can be long-lasting and have negative impact on the physical and mental health of the patients. However, its first-line treatment, isotretinoin, can lead to unacceptable side effects, which greatly limits its clinical application. It is very urgent to find new treatments for acne. A previous study showed that a disorder of the gut microbiota (bacteria) occurred in patients with acne. Omega-3 (ω-3) fatty acids have attracted extensive attention due to their strong anti-inflammatory effects and positive effects on gut microbiota. Therefore, the aim of this study is to find out whether ω-3 fatty acids can treat acne vulgaris by regulating gut microbiota and its metabolites.
Who can participate?
Healthy volunteers or patients with moderate and severe acne vulgaris, at least 18 years of age, maximum age 30 years.
What does the study involve?
The healthy volunteers do not receive any treatment. All patients are randomly allocated to oral isotretinoin in combination with (or without) omega-3 (ω-3) fatty acids for 12 weeks. Skin tests are carried out and blood and feces samples are collected at the start of the study and after 12 weeks of treatment.
What are the possible benefits and risks of participating?
Patients could benefit from the treatment and their clinical symptoms may be relieved to some extent. This study may find a new treatment for acne. The main risk comes from the side effects of isotretinoin, such as dry mucous membranes, elevated liver enzymes, dyslipidemia and fetal malformation. If the patient has adverse reactions due to the test drug during the treatment, the researcher should immediately terminate the patient to continue the trial.
Where is the study run from?
Affiliated Hospital of Southwest Medical University (China)
When is the study starting and how long is it expected to run for?
July 2019 to December 2021
Who is funding the study?
1. Joint project of Southwest Medical University and Suining People's Hospital (China)
2. Joint project of Southwest Medical University and Luzhou Science and Technology Bureau (China)
3. Project of Sichuan Provincial Department of Science and Technology (China)
4. National Natural Science Foundation of China (China)
5. Southwest Medical University (China)
Who is the main contact?
Yongqiong Deng, dengyongqiong1@126.com
Contact information
Scientific
Department of Dermatology & STD
Affiliated Hospital of Southwest Medical University
No. 25, Taiping Street
Luzhou
646000
China
 ORCID ID |
0000-0003-2023-830X |
|---|---|
| Phone | +86 (0)8303165232 |
| dengyongqiong1@126.com |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A clinical study on the adjuvant treatment of ω-3 fatty acids in moderate and severe acne vulgaris through positive regulation of disordered gut microbiota |
| Study objectives | ω-3 fatty acids could play a therapeutic role in moderate and severe acne vulgaris patients by regulating gut microbiota |
| Ethics approval(s) | Approved 03/07/2020, the clinical trial ethics committee of the Affiliated Hospital of Southwest Medical University (No. 25, Taiping Street, Luzhou, 646000, Sichuan Province, China; +86 (0)8303165273; xnydfyirb@sina.com), ref: KY2020115 |
| Health condition(s) or problem(s) studied | Moderate and severe acne vulgaris |
| Intervention | The healthy volunteers do not receive any treatment. All patients are randomized (using a computational random grouping table made by IBM SPSS Statistics 21.0) to oral isotretinoin in combination with (or without) omega-3 (ω-3) fatty acids for 12 weeks. The ω-3 fatty acids are given at a dose of 2400 mg/d. The isotretinoin is started at the initial doses of 0.5-1.0 mg/ (kg.d), then adjusted according to the drug side effects, and the curative effect is evaluated by the Global Acne Grading System (GAGS). When the GAGS is 19 ~ 30, the dose of isotretinoin is given by 0.5 mg/ (kg.d). If the GAGS >30, the researchers increase the dose of isotretinoin to 1.0 mg/ (kg.d). If the patient's primary skin lesions gradually improve without new skin lesions occurring, the dose of isotretinoin is reduced to 0.5 mg/ (kg.d) by degrees. The collection of samples from the patients is arranged at baseline and after 12 weeks of treatment. The ω- 3 fatty acids are packed in a sealed package with a unique number. During the whole study, the researcher distributes the drug according to the drug number of each subject, and the drug number shall not be changed. |
| Intervention type | Supplement |
| Primary outcome measure | 16s rDNA sequence measured from fresh fecal sample at baseline and after 12 weeks of treatment |
| Secondary outcome measures | 1. Disease severity of acne vulgaris measured using the Global Acne Grading System (GAGS) at baseline and after 12 weeks of treatment 2. The percentage of red area and porphyrins on the front, left and right sides measured respectively using the VISIA-CR™ imaging system at baseline and after 12 weeks of treatment 3. The levels of blood glucose, cholesterol, triglyceride, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) from fasting venous blood measured enzymatically with an automatic analyser at baseline and after 12 weeks of treatment 4. Fasting insulin measured using ELISA at baseline and after 12 weeks of treatment 5. Insulin resistance measured using the homeostasis model assessment of insulin resistance (HOMA-IR) at baseline and after 12 weeks of treatment 6. Serum sample collected for liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis at baseline and after 12 weeks of treatment |
| Overall study start date | 01/07/2019 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. Patients who meet the criteria for diagnosis and classification of moderate and severe acne vulgaris or healthy volunteers 2. Male or female, at least 18 years of age, maximum age 30 years 3. Body mass index (BMI) 18-25 kg/m² 4. No isotretinoin and ω-3 fatty acids were taken orally within 6 months 5. No drugs were systematically applied within 6 months 6. Participants who have signed the informed consent |
| Key exclusion criteria | 1. Participants with other skin diseases. 2. Participants with immune deficiency or other immune diseases 3. Participants with metabolic diseases such as diabetes and hyperlipidemia 4. Participants with tumors and other serious medical diseases 5. Smokers and alcoholics 6. Pregnant and lactating women 7. Participants who had undergone gastrointestinal surgery 8. Participants with the allergic constitution 9. Participants who known to be allergic to isotretinoin and ω-3 fatty acids 10. Participants who refuse to sign the informed consent form |
| Date of first enrolment | 10/07/2020 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- China
Study participating centre
No. 25, Taiping Street
Luzhou
646000
China
Sponsor information
Hospital/treatment centre
No. 25, Taiping Street
Luzhou
Luzhou
646000
China
| Phone | +86 (0)8303165200 |
|---|---|
| xcb026@126.com | |
| Website | http://www.ahswmu.cn |
"ROR" |
https://ror.org/0014a0n68 |
Funders
Funder type
Government
No information available
No information available
Government organisation / Local government
- Alternative name(s)
- Sichuan Provincial Department of Science and Technology, Department of Science and Technology of Sichuan Province, Science & Technology Department of Sichuan Province, 四川省科学技术厅, SPDST
- Location
- China
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Government organisation / Universities (academic only)
- Alternative name(s)
- 西南医科大学, SWMU
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers plan to publish in high-impact peer-reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yongqiong Deng (dengyongqiong1@126.com). Individual participant data that underlie the results will be available upon request after publication and ending 12 months after publication. The datasets are stored on spreadsheets and all appropriate requests for appropriate analysis and mechanisms will be considered. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/01/2024 | 03/01/2024 | Yes | No |
Editorial Notes
03/01/2024: Publication reference added.
07/09/2022: Trial's existence confirmed by the clinical trial ethics committee of the Affiliated Hospital of Southwest Medical University.
