Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation in the Suction Blister Model

NCT05311033 | Completed

• 1 other identifier: 21-PP-07
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Pigmentation

Outcome Measures

Primary Outcomes (1)

• 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

  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

  at Day 29 and Day 64

Study Arms (1)

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)

Other: Exacyl

Interventions

Exacyl OTHER

Healthy males with at risk of post-inflammatory hyperpigmentation have a skin samples for evaluate the activity of tranexamic acid.

Samples Without DNA

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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,
• 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,

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-maritimes, 06200, France

Location

MeSH Terms

Conditions

Pigmentation Disorders

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• passeron thierry, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 5, 2022
• Study Start: January 4, 2023
• Primary Completion: October 29, 2024
• Study Completion: August 18, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)