Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk.
The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects.
The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K40a | Experimental | K40a is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. |
|
| K40b | Experimental | K40b is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. |
|
| Placebo | Placebo Comparator | Placebo is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K40a | Drug | One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema and desquamation scores | Sum of erythema and desquamation scores at Week 4 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema and desquamation scores | Sum of erythema and desquamation scores at Week 2 and 8 | Weeks 2 and 8 |
| Responder | Responder defined as a patient with complete remission (sum of erythema and desquamation scores=0) or partial remission (sum of scores=1 or 2) at Week 2, 4 and 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lennart Emtestam, MD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dellenkliniken | Delsbo | Sweden | ||||
| Läkarhuset Farsta Centrum |
Not provided
| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| K40b | Drug | One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. |
|
| Placebo | Drug | One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week. |
|
| Weeks 2, 4 and 8 |
| Erythema score | Erythema score at Week 2, 4 and 8 | Weeks 2, 4 and 8 |
| Desquamation score | Desquamation score at Week 2, 4 and 8 | Weeks 2, 4 and 8 |
| Doctor's Global evaluation | Doctor's Global evaluation at Week 4 and 8 | Week 4 and 8 |
| Patient's Global evaluation | Patient's Global evaluation at Week 4 and 8 | Weeks 4 and 8 |
| Pruritus score | Patient's pruritus score at Week 2, 4 and 8 | Weeks 2, 4 and 8 |
| Dandruff score | Patient's dandruff score at Week 2, 4 and 8 | Weeks 2, 4 and 8 |
| Dermatology Life Quality Index | Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8 | Week 4 and 8 |
| Ease of application | Cosmetic properties; ease of application at Week 4 and 8 | Weeks 4 and 8 |
| Stickiness | Cosmetic properties; stickiness at Week 4 and 8 | Weeks 4 and 8 |
| Effect on hair quality | Cosmetic properties; effect on hair quality at Week 4 and 8 | Weeks 4 and 8 |
| Adverse events | Adverse Events classified by body system and preferred term | Weeks 0, 2, 4 and 8 |
| Farsta |
| Sweden |
| Stortorgets Hälsocentral | Gävle | Sweden |
| Hedesunda Hälsocentral | Hedesunda | Sweden |
| Familjehälsan | Hofors | Sweden |
| Derbykliniken | Malmö | Sweden |
| Möllevångens Läkargrupp, | Malmö | Sweden |
| Möllevångens Läkargrupp | Malmö | Sweden |
| Österpraktiken | Örebro | Sweden |
| Department of Dermatology, Karolinska University Hospital | Stockholm | Sweden |
| Hälsojouren | Uppsala | Sweden |
| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |