Acne VulgarisNCT07069075
Gene Polymorphisms, Skin Barrier, and Inflammation in Acne
An observational study of Acne Vulgaris, run by Hong Zhang at 1 site in China.
Trial summary
This study investigated the relationship between Matrix Metalloproteinase-2 (MMP-2) and Tissue Inhibitor of Metalloproteinase-2 (TIMP-2) gene polymorphisms and acne pathogenesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- MMP-2 Gene Polymorphism (rs243865) Analysis and TIMP-2 Gene Polymorphism (rs8179090) Analysis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 30 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acne vulgaris and healthy volunteers recruited from the dermatology department of Shijiazhuang TCM Hospital.
Who may be able to join
- Aged 18 years or older, regardless of gender.
- Diagnosed with acne by a dermatologist (for patient group).
- No systemic or skin diseases (for control group).
- Able to provide informed consent and willing to undergo genotype testing and related skin function tests.
Who cannot join
- Acne induced by medications.
- Polycystic ovary syndrome or other forms of hormone-related acne.
- Any local, systemic, or surgical acne/acne scar treatments within the last four weeks.
- Presence of genetic connective tissue diseases.
- Associated with pyoderma or other systemic comorbidities.
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between MMP-2 and TIMP-2 Gene Polymorphisms and Skin Barrier Function, Inflammatory Cytokine Levels in Acne Patients
This study investigated the relationship between Matrix Metalloproteinase-2 (MMP-2) and Tissue Inhibitor of Metalloproteinase-2 (TIMP-2) gene polymorphisms and acne pathogenesis. The study aimed to determine whether specific genotypes (MMP-2-CC and TIMP-2-CC) are associated with impaired skin barrier function (measured by transepidermal water loss and skin hydration) and elevated levels of inflammatory cytokines (IL-1β, TNF-α) in acne patients compared to healthy controls.
Read the detailed description
Acne vulgaris is a common dermatological condition with a complex pathogenesis involving skin barrier dysfunction and inflammation. Matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs) are crucial in extracellular matrix remodeling and have been implicated in acne. This case-control study was designed to explore the association of specific polymorphisms in the MMP-2 (rs243865) and TIMP-2 (rs8179090) genes with clinical and biological markers in acne. A total of 200 acne patients and 100 healthy controls were enrolled. Genomic DNA was extracted from peripheral blood samples, and genotyping was performed using PCR-RFLP. Skin barrier function was assessed by measuring Transepidermal Water Loss (TEWL) and skin hydration. Serum levels of the inflammatory cytokines Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α) were quantified using ELISA. The study evaluates whether the CC genotypes of MMP-2 and TIMP-2 are risk factors for acne susceptibility and are correlated with more severe disease phenotypes, characterized by poorer skin barrier integrity and a heightened inflammatory state.
- Conditions
- Acne Vulgaris
- Being tested
- MMP-2 Gene Polymorphism (rs243865) Analysis, TIMP-2 Gene Polymorphism (rs8179090) Analysis
- Keywords
- Acne, MMP-2, TIMP-2, Gene Polymorphism
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMP-2 Gene Polymorphism (rs243865) AnalysisGenetic
Participants were genotyped for the MMP-2 rs243865 polymorphism. Genomic DNA was extracted from peripheral blood, and the specific genotype (CC, CT, or TT) was determined using Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) analysis. This allowed for the stratification of participants based on their genetic variation at this locus for subsequent association analysis.
TIMP-2 Gene Polymorphism (rs8179090) AnalysisGenetic
Participants were genotyped for the TIMP-2 rs8179090 polymorphism. Genomic DNA was extracted from peripheral blood, and the specific genotype (CC, GC, or GG) was determined using Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) analysis. This allowed for the stratification of participants based on their genetic variation at this locus for subsequent association analysis.
| Study group | Role | What they receive |
|---|---|---|
| Acne Patients | Individuals aged 18 years or older who were diagnosed with acne vulgaris by a dermatologist. Participants provided blood samples for genotyping and cytokine analysis, and underwent non-invasive skin function tests. Receives: Genetic: MMP-2 Gene Polymorphism (rs243865) Analysis; Genetic: TIMP-2 Gene Polymorphism (rs8179090) Analysis | |
| Healthy Controls | Healthy volunteers aged 18 years or older without any systemic or skin diseases, recruited during the same period. Participants provided blood samples for genotyping. Receives: Genetic: MMP-2 Gene Polymorphism (rs243865) Analysis; Genetic: TIMP-2 Gene Polymorphism (rs8179090) Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype Frequencies of MMP-2 and TIMP-2
Comparison of the genotype distribution (CC vs. CT/TT for MMP-2; CC vs. GC/GG for TIMP-2) between acne patients and healthy controls to assess association with acne susceptibility. [Time Frame: Data collected at a single study visit] Skin Barrier Function Assessment: Measurement of Transepidermal Water Loss (TEWL) and skin hydration levels in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Measured: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Skin Barrier Function Assessment
Measurement of Transepidermal Water Loss (TEWL) and skin hydration levels in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Measured: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Serum Interleukin-1β (IL-1β) Level
Measurement of serum levels of IL-1β in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Measured: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Serum Tumor Necrosis Factor-α (TNF-α) Level
Measurement of serum levels of TNF-α in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Measured: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Secondary outcomes (1)
Correlation Analysis
Pearson correlation and logistic regression analyses to evaluate the association between the MMP-2/TIMP-2 genotypes, impaired skin barrier function, and elevated inflammatory cytokine levels in acne patients.
Measured: Analysis was performed after the completion of data collection in September 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Aug 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Zhang, Shijiazhuang TCM Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069075
- Sponsor's protocol ID
- 2020SJZTCMLL-KY0045
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Fang L, Zhang M, Sun S, Zhi H, Zhu Y, Zhang H. The relationship between MMP-2 and TIMP-2 gene polymorphisms and skin barrier function, inflammatory cytokine levels in acne patients. Expert Rev Clin Immunol. 2026 Feb;22(2):233-241. doi: 10.1080/1744666X.2026.2636646. Epub 2026 Mar 4.
PubMed 41730533
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between MMP-2 and TIMP-2 Gene Polymorphisms and Skin Barrier Function, Inflammatory Cytokine Levels in Acne Patients
- ClinicalTrials.gov ID
- NCT07069075
- Acronym / sponsor ID
- 2020SJZTCMLL-KY0045
- Conditions
- Acne Vulgaris
- Keywords
- Acne, MMP-2, TIMP-2, Gene Polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hong ZhangUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Jul 2025 (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.
This study investigated the relationship between Matrix Metalloproteinase-2 (MMP-2) and Tissue Inhibitor of Metalloproteinase-2 (TIMP-2) gene polymorphisms and acne pathogenesis. The study aimed to determine whether specific genotypes (MMP-2-CC and TIMP-2-CC) are associated with impaired skin barrier function (measured by transepidermal water loss and skin hydration) and elevated levels of inflammatory cytokines (IL-1β, TNF-α) in acne patients compared to healthy controls.
Detailed description
Acne vulgaris is a common dermatological condition with a complex pathogenesis involving skin barrier dysfunction and inflammation. Matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs) are crucial in extracellular matrix remodeling and have been implicated in acne. This case-control study was designed to explore the association of specific polymorphisms in the MMP-2 (rs243865) and TIMP-2 (rs8179090) genes with clinical and biological markers in acne. A total of 200 acne patients and 100 healthy controls were enrolled. Genomic DNA was extracted from peripheral blood samples, and genotyping was performed using PCR-RFLP. Skin barrier function was assessed by measuring Transepidermal Water Loss (TEWL) and skin hydration. Serum levels of the inflammatory cytokines Interleukin-1β (IL-1β) and Tumor Necrosis Factor-α (TNF-α) were quantified using ELISA. The study evaluates whether the CC genotypes of MMP-2 and TIMP-2 are risk factors for acne susceptibility and are correlated with more severe disease phenotypes, characterized by poorer skin barrier integrity and a heightened inflammatory state.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne Patients | – | Genetic: MMP-2 Gene Polymorphism (rs243865) Analysis, Genetic: TIMP-2 Gene Polymorphism (rs8179090) AnalysisIndividuals aged 18 years or older who were diagnosed with acne vulgaris by a dermatologist. Participants provided blood samples for genotyping and cytokine analysis, and underwent non-invasive skin function tests. |
| Healthy Controls | – | Genetic: MMP-2 Gene Polymorphism (rs243865) Analysis, Genetic: TIMP-2 Gene Polymorphism (rs8179090) AnalysisHealthy volunteers aged 18 years or older without any systemic or skin diseases, recruited during the same period. Participants provided blood samples for genotyping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acne vulgaris and healthy volunteers recruited from the dermatology department of Shijiazhuang TCM Hospital.
Key inclusion criteria (4 listed)
- Aged 18 years or older, regardless of gender.
- Diagnosed with acne by a dermatologist (for patient group).
- No systemic or skin diseases (for control group).
- Able to provide informed consent and willing to undergo genotype testing and related skin function tests.
Key exclusion criteria (6 listed)
- Acne induced by medications.
- Polycystic ovary syndrome or other forms of hormone-related acne.
- Any local, systemic, or surgical acne/acne scar treatments within the last four weeks.
- Presence of genetic connective tissue diseases.
- Associated with pyoderma or other systemic comorbidities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMP-2 Gene Polymorphism (rs243865) AnalysisParticipants were genotyped for the MMP-2 rs243865 polymorphism. Genomic DNA was extracted from peripheral blood, and the specific genotype (CC, CT, or TT) was determined using Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) analysis. This allowed for the stratification of participants based on their genetic variation at this locus for subsequent association analysis. | Genetic | Acne Patients, Healthy Controls |
| TIMP-2 Gene Polymorphism (rs8179090) AnalysisParticipants were genotyped for the TIMP-2 rs8179090 polymorphism. Genomic DNA was extracted from peripheral blood, and the specific genotype (CC, GC, or GG) was determined using Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) analysis. This allowed for the stratification of participants based on their genetic variation at this locus for subsequent association analysis. | Genetic | Acne Patients, Healthy Controls |
Primary outcome
Genotype Frequencies of MMP-2 and TIMP-2
Time frame: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Comparison of the genotype distribution (CC vs. CT/TT for MMP-2; CC vs. GC/GG for TIMP-2) between acne patients and healthy controls to assess association with acne susceptibility. [Time Frame: Data collected at a single study visit] Skin Barrier Function Assessment: Measurement of Transepidermal Water Loss (TEWL) and skin hydration levels in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Skin Barrier Function Assessment
Time frame: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Measurement of Transepidermal Water Loss (TEWL) and skin hydration levels in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Serum Interleukin-1β (IL-1β) Level
Time frame: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Measurement of serum levels of IL-1β in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
Serum Tumor Necrosis Factor-α (TNF-α) Level
Time frame: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.
Measurement of serum levels of TNF-α in acne patients, compared across different MMP-2 and TIMP-2 genotypes.
1 secondary outcome
Correlation Analysis
Time frame: Analysis was performed after the completion of data collection in September 2021.
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 16 Jul 2025.
- Derived from this study: PubMed 41730533Huang S, Fang L, Zhang M, Sun S, Zhi H, Zhu Y, Zhang H. The relationship between MMP-2 and TIMP-2 gene polymorphisms and skin barrier function, inflammatory cytokine levels in acne patients. Expert Rev Clin Immunol. 2026 Feb;22(2):233-241. doi: 10.1080/1744666X.2026.2636646. Epub 2026 Mar 4.
Related trials for Acne Vulgaris
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hong Zhang at 1 site in China.
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 6 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 16 Jul 2025. 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 China. 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?
Genotype Frequencies of MMP-2 and TIMP-2 (time frame: Data for each participant were collected at a single visit during the study period from March 2018 to September 2021.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07069075, which also lists 1 linked publication.
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 16 Jul 2025.