Skin PigmentationTRANEXNCT05311033
Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation in the Suction Blister Model
A study testing Exacyl in people with Skin Pigmentation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Post-inflammatory hyperpigmentation (PIH) is a common sequela of inflammatory dermatoses. PIH results from the overproduction of melanin or irregular pigment dispersion after skin inflammation. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Pigmentation
- What is being tested?
- Exacyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2023to 18 Aug 2025
- Phase
- Interventional
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject who has signed and dated an information and informed consent form before any study-related procedure is initiated,
- A healthy male subject between the ages of 20 and 40 years
- Subject at risk of HPPI: phototype IV or V according to the Fitzpatrick scale (1) and having a colorimetric individual typology angle (ITA°) between -20°/ and 28° and/or having previous post-inflammatory gold pigmentation or hyperpigmentation (e.g. acne scars, melasma)
- Subjects willing to undergo skin biopsies and who do not have any contraindications related to biopsy procedures such as allergy to local anaesthetics or local antiseptics (Chlorhexidine), coagulation problems, having an anticoagulant treatment or a history of wound healing problems or vasovagal hypotension or syncope.
- Subject willing to follow the study restrictions and willing to complete the study,
- Subject covered by a Social Security scheme in accordance with the Public Health Code (Article L1121-11)
Who cannot join
- Subjects with contraindications to tranexamic acid :
- Subjects allergic to tranexamic acid or to any of the other components contained in Exacyl,
- Subject suffering from arterial or venous thrombosis,
- Subjects with a history of thromboembolic disease or with an increased incidence of thromboembolic events in their family history (patients at high risk of thrombophilia)
- Subjects with consumer coagulopathy,
- Subjects with kidney problems,
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- Subjects with a history of seizures
- Subjects allergic to wheat as Exacyl contains wheat starch
- Subject with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency
- Subjects with active systemic or skin disease that could in any way interact with the interpretation of the study results (e.g. atopic dermatitis or psoriasis),
- Subjects who are planning to be exposed to intense sunlight during the study or who have been exposed within 6 weeks prior to the screening visit,
- Subject having used any anti-inflammatory product (steroidal and non-steroidal anti-inflammatory drugs) for more than 5 consecutive days in the month prior to inclusion or having planned to use these drugs during the study,
- Subjects taking treatments known to be active on skin healing,
- Subjects with a significant history of alcohol or drug abuse or with a psychotic state,
- Subject with a history of keloids or hypertrophic scars,
- Subject with a positive hepatitis B, hepatitis C or HIV status at the screening visit,
- Subject with a history of serious illness (based on the subject's history and/or the results of the screening physical examination) that, in the opinion of the Investigator, would place the subject at risk by participating in the study or would significantly interfere with the evaluation of the study outcome (e.g. cancer, immunity disorder),
- Subjects who are hospitalised in a medical or social institution for any reason other than biomedical research or who have lost their liberty by administrative or legal decision or who are under guardianship,
- Subject unable to communicate or cooperate with the Investigator due to mental impairment, language problems or impaired brain function,
- Subject who has received treatment with a non-marketed substance in the 4 weeks prior to inclusion or longer, if the substance family requires a longer wash-out period,
- Subject who has received (or will receive) more than 4500 euros in compensation for participation in clinical studies during the 12 months preceding the study.
- Subjects protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation Induced in the Suction Blister Model - Study HPPI
Post-inflammatory hyperpigmentation (PIH) is a common sequela of inflammatory dermatoses. PIH results from the overproduction of melanin or irregular pigment dispersion after skin inflammation. The investigators have developed, validated and published an in vivo model of PIH based on an initial lesion involving suction blisters. In this study, they have demonstrated that the suction blisters model is able to reproduce an epidermal lesion and inflammatory state that, in melanin competent subjects, leads to consistent hyperpigmentation during real sunlight exposure without the need for additional artificial exposure to intense UV light.
An increase in vascularisation is demonstrated by histology in early forms of PIH. The investigators have also shown this increase in vascularisation in their PIH model. Furthermore, the transcriptomic study in this model shows that UVA and visible light directly stimulate endothelial cells and increase angiogenesis but act essentially indirectly through the production by fibroblasts of uPA (urokinase-type plasminogen activator), a key factor in the modulation of extracellular matrices, inflammatory processes and angiogenesis.
Read more
UPA is a serine protease that converts plasminogen to plasmin which promotes angiogenesis. Tranexamic acid (TA) is an antifibrinolytic that reversibly binds to plasminogen, preventing its conversion to plasmin and subsequent fibrin degradation.
The aim of the study will be to evaluate the efficacy of tranexamic acid in preventing post-inflammatory hyperpigmentation induced in the suction blisters model in at-risk subjects.
- Conditions
- Skin Pigmentation
- Being tested
- Exacyl
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExacylOther
Healthy males with at risk of post-inflammatory hyperpigmentation have a skin samples for evaluate the activity of tranexamic acid.
| Study group | Role | What they receive |
|---|---|---|
| Samples Without DNA | Experimental | Healthy males aged 20-40 years with at risk of post-inflammatory hyperpigmentation: phototype IV or V according to the Fitzpatrick scale (1) and having a colorimetric individual typology angle (ITA°) between -20° and 28° and/or having already had post-inflammatory pigmentation or hyperpigmentation (e.g. acne scars, melasma) Receives: Other: Exacyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline post-inflammatory hyperpigmentation induced in the suction blister model Systolic Blood Pressure at 6 months
To evaluate the activity of tranexamic acid on the prevention of post-inflammatory hyperpigmentation induced in the suction blister model in subjects at risk
Measured: at Day 1 (baseline) and 72 days
Secondary outcomes (1)
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the tolerance and possible adverse effects during 5 weeks of tranexamic acid treatment on post-inflammatory hyperpigmentation induced in the suction blister model
Measured: at Day 29 and Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start4 Jan 2023
- Primary completion29 Oct 2024
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PigmentationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- passeron thierry, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311033
- Sponsor's protocol ID
- 21-PP-07
- Acronym
- TRANEX
- Status last verified
- Sep 2025
- First submitted
- 7 Mar 2022
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation Induced in the Suction Blister Model - Study HPPI
- ClinicalTrials.gov ID
- NCT05311033
- Acronym / sponsor ID
- TRANEX / 21-PP-07
- Conditions
- Skin Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 5 Apr 2022 (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.
Post-inflammatory hyperpigmentation (PIH) is a common sequela of inflammatory dermatoses. PIH results from the overproduction of melanin or irregular pigment dispersion after skin inflammation. The investigators have developed, validated and published an in vivo model of PIH based on an initial lesion involving suction blisters. In this study, they have demonstrated that the suction blisters model is able to reproduce an epidermal lesion and inflammatory state that, in melanin competent subjects, leads to consistent hyperpigmentation during real sunlight exposure without the need for additional artificial exposure to intense UV light.
An increase in vascularisation is demonstrated by histology in early forms of PIH. The investigators have also shown this increase in vascularisation in their PIH model. Furthermore, the transcriptomic study in this model shows that UVA and visible light directly stimulate endothelial cells and increase angiogenesis but act essentially indirectly through the production by fibroblasts of uPA (urokinase-type plasminogen activator), a key factor in the modulation of extracellular matrices, inflammatory processes and angiogenesis.
UPA is a serine protease that converts plasminogen to plasmin which promotes angiogenesis. Tranexamic acid (TA) is an antifibrinolytic that reversibly binds to plasminogen, preventing its conversion to plasmin and subsequent fibrin degradation.
The aim of the study will be to evaluate the efficacy of tranexamic acid in preventing post-inflammatory hyperpigmentation induced in the suction blisters model in at-risk subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samples Without DNA | Experimental | Other: ExacylHealthy males aged 20-40 years with at risk of post-inflammatory hyperpigmentation: phototype IV or V according to the Fitzpatrick scale (1) and having a colorimetric individual typology angle (ITA°) between -20° and 28° and/or having already had post-inflammatory pigmentation or hyperpigmentation (e.g. acne scars, melasma) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject who has signed and dated an information and informed consent form before any study-related procedure is initiated,
- A healthy male subject between the ages of 20 and 40 years
- Subject at risk of HPPI: phototype IV or V according to the Fitzpatrick scale (1) and having a colorimetric individual typology angle (ITA°) between -20°/ and 28° and/or having previous post-inflammatory gold pigmentation or hyperpigmentation (e.g. acne scars, melasma)
- Subjects willing to undergo skin biopsies and who do not have any contraindications related to biopsy procedures such as allergy to local anaesthetics or local antiseptics (Chlorhexidine), coagulation problems, having an anticoagulant treatment or a history of wound healing problems or vasovagal hypotension or syncope.
- Subject willing to follow the study restrictions and willing to complete the study,
Key exclusion criteria (22 listed)
- Subjects with contraindications to tranexamic acid :
- Subjects with active systemic or skin disease that could in any way interact with the interpretation of the study results (e.g. atopic dermatitis or psoriasis),
- Subjects who are planning to be exposed to intense sunlight during the study or who have been exposed within 6 weeks prior to the screening visit,
- Subject having used any anti-inflammatory product (steroidal and non-steroidal anti-inflammatory drugs) for more than 5 consecutive days in the month prior to inclusion or having planned to use these drugs during the study,
- Subjects taking treatments known to be active on skin healing,
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 |
|---|---|---|
| ExacylHealthy males with at risk of post-inflammatory hyperpigmentation have a skin samples for evaluate the activity of tranexamic acid. | Other | Samples Without DNA |
Primary outcome
Change from Baseline post-inflammatory hyperpigmentation induced in the suction blister model Systolic Blood Pressure at 6 months
Time frame: at Day 1 (baseline) and 72 days
To evaluate the activity of tranexamic acid on the prevention of post-inflammatory hyperpigmentation induced in the suction blister model in subjects at risk
1 secondary outcome
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: at Day 29 and Day 64
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 10 Sep 2025.
- 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.
passeron thierry, PhD principal investigator
CHU de Nice, Service de Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exacyl in people with Skin Pigmentation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 22 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 10 Sep 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 France. 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?
Change from Baseline post-inflammatory hyperpigmentation induced in the suction blister model Systolic Blood Pressure at 6 months (time frame: at Day 1 (baseline) and 72 days). 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 10 Sep 2025.