Neurobiology of the Scalp in Seborrheic Dermatitis

NCT02349854 | Completed

• 1 other identifier: H-31892
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Dermatitis

Keywords

pruritus; itch; skin; scalp; seborrheic dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of vasodilatory peptidergic nerve fibers in the papillary dermis versus total nerves in the papillary dermis in control versus diseased scalp

  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).

  one year

Secondary Outcomes (5)

• Presence or absence of brush-stoke induced pruritus in disease versus control skin

  one year

• Duration (minutes) of cowhage-spicule induced pruritus in diseases versus control skin

  1 year

• Amount of pin-pressure induced pruritus in diseased versus control skin

  one year

• Amount of thermal (sensation of mildly painful and non-damaging heat)-induced itch in diseased versus control skin

  one year

• Percent of autonomic nerves to total nerves innervating adnexal structures in diseased versus control skin

  one year

Study Arms (2)

Cases

patients with scalp itch and seborrheic dermatitis who will get biopsy

Procedure: Biopsy

Controls

patients without scalp itch and without seborrheic dermatitis who will get biopsy

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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.

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dermatology clinic patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• L'Oreal: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Scalp biopsy

MeSH Terms

Conditions

Dermatitis, Seborrheic; Pruritus

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Deon Wolpowitz, MDPhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)