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Neurobiology of the Scalp in Seborrheic Dermatitis

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ClinicalTrials.gov Identifier: NCT02349854
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
L'Oreal
Information provided by (Responsible Party):
Boston University

Brief Summary:
Seborrheic dermatitis is a common, inflammatory skin condition that causes flaky, white to yellowish scales to form on oily areas such as the scalp or inside the ear. These scales can occur with or without underlying reddened skin. In addition to causing psychological distress, low self esteem, and embarrassment, seborrheic dermatitis is associated with scalp pruritus (itch). Treatment modalities exist to control scalp flaking and itch associated with seborrheic dermatitis, although such therapies often lose efficacy over time. As seborrheic dermatitis is a chronic (life-long) condition, better treatments are needed. The investigators propose to better characterize in subjects with seborrheic dermatitis involving the scalp versus normal scalp controls: (a) the clinical characteristics of the associated itch and (b) the pattern of nerve innervation to the scalp. In this way, the investigators hope to get a comprehensive understanding of the factors causing scalp itch with the aim that this information will create new candidates to which treatment modalities can be designed. At least 12 (up to 20) subjects and similar number of control subjects without disease will have one clinic visit including questionnaires, testing of sensation on the scalp, and biopsy of the scalp.

Condition or disease Intervention/treatment
Seborrheic Dermatitis Procedure: Biopsy

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neurobiology of the Scalp in Seborrheic Dermatitis
Actual Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
patients with scalp itch and seborrheic dermatitis who will get biopsy
Procedure: Biopsy
1 scalp biopsy will be done at the site of central sensitization testing, according to standard of care practices. First, the site will be anesthetized and within this area, 2 immediately adjacent (ie contiguous) punch biopsies will be taken-2mm & 3mm. Both will be closed simultaneously using either (i) non fast-absorbing gut sutures, requiring a 10-14 day follow-up visit for suture removal; (ii) fast absorbing gut sutures that will not require a subsequent suture removal visit, or (iii) gel foam without stitches that also does not require a suture removal visit. Wound care instruction will be discussed with patient. The patient will be instructed to apply petroleum jelly at least 3 times per day to the biopsy site, reflecting standard of care clinical care at BMC.

Controls
patients without scalp itch and without seborrheic dermatitis who will get biopsy
Procedure: Biopsy
1 scalp biopsy will be done at the site of central sensitization testing, according to standard of care practices. First, the site will be anesthetized and within this area, 2 immediately adjacent (ie contiguous) punch biopsies will be taken-2mm & 3mm. Both will be closed simultaneously using either (i) non fast-absorbing gut sutures, requiring a 10-14 day follow-up visit for suture removal; (ii) fast absorbing gut sutures that will not require a subsequent suture removal visit, or (iii) gel foam without stitches that also does not require a suture removal visit. Wound care instruction will be discussed with patient. The patient will be instructed to apply petroleum jelly at least 3 times per day to the biopsy site, reflecting standard of care clinical care at BMC.




Primary Outcome Measures :
  1. Percentage of vasodilatory peptidergic nerve fibers in the papillary dermis versus total nerves in the papillary dermis in control versus diseased scalp [ Time Frame: one year ]
    Hypothesis: Scalp pruritus in patients with seborrheic dermatitis is associated with a change in the neuropeptide identity of nerves at the dermal-epidermal junction (DEJ).


Secondary Outcome Measures :
  1. Presence or absence of brush-stoke induced pruritus in disease versus control skin [ Time Frame: one year ]
    (i) assessment of brush-stroke induced pruritus: involved and non-involved skin areas chosen for other tests of central sensitization will be stroked smoothly and lightly by a cotton swab or a small paint brush at a rate of 1 Hz. The participants will be asked to report the evoked sensation.

  2. Duration (minutes) of cowhage-spicule induced pruritus in diseases versus control skin [ Time Frame: 1 year ]
    Pinprick stimuli will be applied to the scalp skin with a series of probes: 2 mL syringe barrel containing a free-floating sterile 27-gauge cannula above which is 1 of these weights: 1.0, 2.3, 3.7, 8.6, or 14.8 g. Each probe will be laid down gently on the skin to prevent damage, and then held for 2 seconds. The subjects will be asked to describe the quality and intensity of the evoked sensation. The intensities of itch and pain will be reported separately on a numeric scale ranging from 0 (no sensation) to 10 (maximal sensation imaginable). This mode of application was reported in a previously published study in patients with atopic dermatitis (Ikoma et al, 2004. Neurology; 62: 212-7)to produce maximal itch sensation of less than 3 and maximal pain sensation of less than 4 on a numeric scale ranging from 0 (no sensation) to 10 (maximal sensation imaginable). This procedure will be repeated 10 times with each load in the area of the scalp that will be selected for skin biopsy.

  3. Amount of pin-pressure induced pruritus in diseased versus control skin [ Time Frame: one year ]
    Pinprick stimuli will be applied to the scalp skin with a series of probes: 2 mL syringe barrel containing a free-floating sterile 27-gauge cannula above which is 1 of these weights: 1.0, 2.3, 3.7, 8.6, or 14.8 g. Each probe will be laid down gently on the skin to prevent damage, and then held for 2 seconds. The subjects will be asked to describe the quality and intensity of the evoked sensation. The intensities of itch and pain will be reported separately on a numeric scale ranging from 0 (no sensation) to 10 (maximal sensation imaginable). This mode of application was reported in a previously published study in patients with atopic dermatitis (Ikoma et al, 2004. Neurology; 62: 212-7)to produce maximal itch sensation of less than 3 and maximal pain sensation of less than 4 on a numeric scale ranging from 0 (no sensation) to 10 (maximal sensation imaginable). This procedure will be repeated 10 times with each load in the area of the scalp that will be selected for skin biopsy.

  4. Amount of thermal (sensation of mildly painful and non-damaging heat)-induced itch in diseased versus control skin [ Time Frame: one year ]
    Thin metal rod (diameter, ~2-3 mm) will be preheated to 41, 46, or 49 °C in a temperature-controlled water bath and then sequentially applied perpendicularly to the skin and held for 10 seconds. These temperatures with this short length of application are not enough to cause thermal damage to the skin. The maximal reported sensation was 3.5 for pain and 2.5 for itch on the above 0-10 scale. The subjects will be asked to rate the intensities of the evoked itch and pain every 2 secs from 0 (first placement) to 20 sec after placement. This procedure will be performed once in the area of the scalp that will be selected for skin biopsy. The area under the curves for both itch and pain perception plotted against time will be compared for each site tested.

  5. Percent of autonomic nerves to total nerves innervating adnexal structures in diseased versus control skin [ Time Frame: one year ]
    Hypothesis: Scalp pruritus in patients with seborrheic dermatitis is associated with a change in the distribution or number of autonomic nerves innervating adnexal structures.


Biospecimen Retention:   Samples Without DNA
Scalp biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dermatology clinic patients
Criteria

Inclusion Criteria:

Study Subjects

  • Individuals 18 years or older
  • Pruritus measured by VAS score for scalp itch greater than or equal to 30 in past week and "dandruff" without skin changes or erythema but with histologic evidence of at least focal or mild epidermal spongiosis
  • Pruritus measured by VAS score for scalp itch greater than or equal to 30 in past week and seborrheic dermatitis, including histologic evidence of at least focal or mild epidermal spongiosis
  • No topical anti-pruritic treatments and no prescribed or over-the-counter topical seborrheic dermatitis treatments for at least 3 weeks before initiation of study, including antifungal shampoos, tar or urea-containing shampoos, selenium sulfide or zinc-containing shampoos, or topical steroids
  • Willingness to forgo elective (ie PRN) use of systemic over-the-counter or prescribed antihistamines to treat conditions other than chronic pruritic skin diseases (for example, seasonal allergies) for at least 3 weeks before initiation of the study

Control Subjects

  • Individuals 18 years or older
  • No pruritus of the scalp as measured by VAS score for scalp itch less than 30 in past week and no "dandruff" or scalp skin changes or erythema and no histologic evidence of at least focal or mild epidermal spongiosis
  • No pruritus of the scalp as measured by VAS score for scalp itch less than 30 in past week and no seborrheic dermatitis, including no histologic evidence of at least focal or mild epidermal spongiosis
  • No topical anti-pruritic treatments and no prescribed or over-the-counter topical seborrheic dermatitis treatments for at least 3 weeks before initiation of study, including antifungal shampoos, tar or urea-containing shampoos, selenium sulfide or zinc-containing shampoos, or topical steroids
  • Willingness to forgo elective (ie PRN) use of systemic over-the-counter or prescribed antihistamines to treat conditions other than chronic pruritic skin diseases (for example, seasonal allergies) for at least 3 weeks before initiation of the study

Exclusion Criteria:

  • Individuals with the diagnosis of psoriasis or evidence of psoriasis in other non-scalp body areas
  • Individuals with evidence of any primary scarring alopecia (active or inactive).
  • Individuals with non-dermatologic scalp itch, including scalp itch with no scale (ie dandruff) or erythema, individuals with senile pruritus of the scalp, or scalp dysthesias (such as in the setting of anxiety/mood disorders).
  • Individuals on anti-depressant medication specifically to treat pruritus. (Patients on anti-depressants for non-pruritus reasons and that meet the VAS criteria for itch will be included).
  • Individuals with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Individuals unable to read and/or comprehend the questionnaires utilized in this study
  • Individuals that present with haircare practices associated with scarring alopecias, such as but not limited to, hot combing, chemical relaxers/straighteners, and tight braiding
  • Individuals with an allergy and/or history of adverse reaction to lidocaine used for the scalp biopsy
  • Any use of systemic anti-pruritic or anti-fungal treatments in the 3 weeks prior to initiation of the study, including systemic corticosteroids, immunosuppressive agents, phototherapy, or antihistamines (in the setting of chronic use for anti-pruritic therapy, such as chronic urticaria)
  • Women who are pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349854


Locations
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United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
L'Oreal
Investigators
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Principal Investigator: Deon Wolpowitz, MDPhD Boston University
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT02349854    
Other Study ID Numbers: H-31892
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
pruritus
itch
skin
scalp
seborrheic dermatitis
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous