Neurobiology of the Scalp in Seborrheic Dermatitis
Completed
Conditions studied: Seborrheic Dermatitis
In brief
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.
Key facts
- Study ID
- NCT02349854
- Run by
- Boston University
- People needed
- 32
- Starts
- 2013-02-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2017-03-27
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Boston University — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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