Health TrialsbyHealthPanel

Pathophysiological Study of the Sensitive Scalp

ConditionSensitive Scalp
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Brest

About this trial

Sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pins and needles) in response to stimuli that should not normally cause them. These unpleasant sensations cannot be explained by lesions attributable to a specific skin disease. Sensitive skin can affect different parts of the body. The scalp is a site that is often affected, with specificity linked in particular to the presence of hair and different triggering factors (styling habits, wearing of head coverings, application of cosmetics to the scalp, etc.). Sensitive scalp affects around half the population, and can have an impact on the quality of life of sufferers, particularly those whose symptoms are very intense. Women are more likely than men to have a sensitive scalp, so in order to have a more homogenous study population, we chose to include 40 women. The pathophysiology of sensitive skin is imperfectly understood, and studies specific to the sensitive scalp are very rare. However, the pathophysiology of the sensitive scalp could be different because it is a hairy area, more innervated, and less exposed to environmental factors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult women without dermatosis

Collection of free and informed consent

patient affiliated to a social security scheme

Disqualifiers

Refusal to take part in the study

Dermatosis of the scalp (psoriasis, seborrhoeic dermatitis, etc.)

Pregnant and breast-feeding women

Women under legal protection (guardianship, curatorship)

Trial design

Design model

Parallel

Treatments tested in this trial

  • A scalp biopsy using a 4 mm punch in the retroauricular hair zone

    Procedure/Surgery

    a scalp biopsy using a 4 mm punch in the retroauricular hair zone under local anesthesia

  • a general health questionnaire

    Other intervention

    a general health questionnaire : demographics, history, treatment, smoking, alcohol consumption, phototype.

  • Questionnaires concerning their sensitive scalp

    Other intervention

    * The characteristics of a sensitive scalp (location, chronicity, triggering and soothing factors, use of cosmetics, etc.) * Sensitive Scalp Score (3S) * Impact on quality of life: BoSS questionnaire * Impact of pruritus on quality of life (ItchyQol)

  • Collection of skin microbiota

    Procedure/Surgery

    The skin microbiome is collected using a sterile swab rubbed against the scalp for 60 seconds

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Case group (patient with sensitive scalp)Other 4 interventions
Group B: Control group (patient with "normal" scalp)Other 3 interventions

Trial outcomes

Primary outcomes

1

Study the pathophysiology of the sensitive scalp based on a study of the genes expressed in the cutaneous tissue

1. mRNA in biopsy by bulk transcriptomic -\> Identify differentially expressed genes between the two groups (sensitive scalp and non-sensitive scalp) 2. mRNA in biopsy by RNAscope -\> Quantify and localized expression of interest's genes

Time frame
1 day

Secondary outcomes

1

Histological study of skin tissue

1. Histological features in biopsies - Routine staining -\> Visualize/Compare skin architecture between the 2 groups (sensitive scalp and non-sensitive scalp), 2. Protein expression in biopsies - immunofluorescent staining -\> Compare the status of keratinocytes between the two groups (sensitive scalp and non-sensitive scalp) 3. Protein expression in biopsies - immunofluorescent staining -\> Compare the Receptors and ion channels expression known to be involved in pruritus between the 2 groups (sensitive scalp and non-sensitive scalp)

Time frame
1 day
2

Study of innervation

1\) Protein expression in biopsies - immunofluorescent staining -\> Quantify free nerve endings in the epidermis and the dermis and compare between the 2 groups (sensitive scalp and non-sensitive scalp)

Time frame
1 day
3

Study of the skin microbiome

Quantification and characterization of microorganisms

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Brest

Lead sponsor

Source ClinicalTrials.gov
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