Tranexamic acid may stop dark spots before they start
NCT ID NCT05311033
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether tranexamic acid, a drug used to control bleeding, can prevent dark spots that often appear after skin inflammation. Ten healthy men at risk for hyperpigmentation will take the drug and have small blisters created on their skin to trigger the spots. Researchers will check if the drug reduces pigmentation and monitor for side effects over five weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tranexamic acid
- What this could lead to
- If it works, this could point toward a way to prevent dark spots after skin inflammation.
- What could go wrong
- This is a very small, early study with only 10 healthy men, so results may not apply to everyone. The treatment is tested on artificial blisters, not real-world skin conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 40 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject who has signed and dated an information and informed consent form before any study-related procedure is initiated, 2. A healthy male subject between the ages of 20 and 40 years 3. 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) 4. 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. 5. Subject willing to follow the study restrictions and willing to complete the study, 6. Subject covered by a Social Security scheme in accordance with the Public Health Code (Article L1121-11) Exclusion Criteria: 1. 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, * 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 2. 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), 3. 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, 4. 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, 5. Subjects taking treatments known to be active on skin healing, 6. Subjects with a significant history of alcohol or drug abuse or with a psychotic state, 7. Subject with a history of keloids or hypertrophic scars, 8. Subject with a positive hepatitis B, hepatitis C or HIV status at the screening visit, 9. 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), 10. 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, 11. Subject unable to communicate or cooperate with the Investigator due to mental impairment, language problems or impaired brain function, 12. 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, 13. 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. 14. Subjects protected by law
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes, 06200, France
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