Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation in the Suction Bliste… (NCT05311033) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation in the Suction Blister Model
France10 participantsStarted 2023-01-04
Plain-language 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. 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.
Who can participate
Age range20 Years – 40 Years
SexMALE
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. Subjects with contraindications to tranexamic acid :
What they're measuring
1
Change from Baseline post-inflammatory hyperpigmentation induced in the suction blister model Systolic Blood Pressure at 6 months
✕. 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,