treating shampoo (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo) 1144628 D cosmetic product

Scalp Dermatitis

Dermatitis

Disulfure de sélénium versus placebo formula

cosmetic product

Interteck

Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis

Multicentric, Randomized, Double Blind Study Under Dermatological Control for Evaluation of the Antidandruff Maintenance Effect of One Shampoo (Reference 1144628 D) Versus Its Vehicle (Reference 1144781) During 8 Weeks After a Ketoconazole-based Antifungal Treatment During 4 Weeks in Adult Subjects (Male and Female) With Light to Moderate Seborrheic Dermatitis

Change at 8 weeks versus Baseline at 8 weeks of the squamous scale of the shampoo versus vehicle

change in scalp microbiome (quantification by Polymerase Chain Reaction of Staphylococcus, Propionibacterium, Malassezia)

change in scalp microbiome (qualification by Next-Generation Sequencing to evaluate diversities)

Antidandruff maintenance effect Comparison of the antidandruff maintenance effect, after a 4 weeks treatment with ketoconazole, of two shampoos (active versus vehicle) applied during 8 weeks i.e. up to week 12 (principal objective) and during 4 and 6 weeks i.e. at week 8 and week 10 (secondary objective).

L'Oreal

Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.

Acne

Tea tree oil

Royal Perth Hospital

Hollywood Private Hospital

Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne

Uncontrolled, Open-label, Phase II Pilot Study to Evaluate the Efficacy, Tolerability and Acceptability of 200mg/g Tea Tree Oil Gel Applied Topically Twice Daily for the Treatment of Mild to Moderate Facial Acne

Numbers of inflamed and non-inflamed facial lesions will be counted.

A 5-point severity scale (0-4) will be used to give an overall acne grade.
0: Clear skin with no lesions
Almost clear; rare lesions
Mild severity; some non-inflammatory lesions with no more than a few inflammatory lesions
Moderate severity; up to many non-inflammatory lesions and may have some inflammatory lesions
Severe; up to many noninflammatory and inflammatory lesions but no more than a few nodular lesions

Decrease in numbers of non-inflammatory lesions from baseline

Decrease in inflammatory lesion count from baseline

Decrease in perceived facial oiliness from baseline

Mean tolerability will be determined as the average of the following;
Erythema
Scaling
Peeling
Burning
Induration
Dryness
These six parameters will be measured using a 5-point scale (0: None, 1: Minimal, 2: Mild, 3: Moderate, 4: Severe). Mean tolerability will be the average of these scores.

Any local or systemic adverse events will be recorded including the type of reaction and severity (on a 5-point severity scale where 0 = none and 4 = severe).

Katherine Hammer

Research Assistant Professor

The University of Western Australia

K301 applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.

Placebo applied topically to the affected area of the scalp once daily during the 4 weeks. Treatment is to be applied before bedtime and can be washed out with the patient's normal shampoo in the morning.

Seborrhoeic Eczema of the Scalp

K301

Placebo

Läkarhuset Farsta Centrum

Centrumläkarna

Kristinelundskliniken Hudläkarmottagningen

Me3plus clinical trials

Hedgrindhälsan AB

Hudmottagningen

Familjehälsan

Din doktor i Stockholm AB

Fruängens Läkarhus

Capio Cityklinik

Limhamns Läkargrupp- Tärnan

Hudläkarna i Linköping

Center för Läkemedelsprövningar

Hudkliniken UMAS

Möllevångens Husläkargrupp

Hjortens VC

VC Silentzvägen Praktikertjänst

Hälsojouren

Läkarhuset Uppsala

K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

A Multicenter, Randomised, Double Blind, Placebo-controlled Study of Efficacy, Safety, and Tolerability of Kaprolac® K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

The sum of erythema and desquamation scores at Week 4

The sum of erythema and desquamation scores at Week 2

Investigator's global evaluation at Week 4

Patient's pruritus/burning score at Week 2 and 4

Adverse events classified by body system and preferred term

dandruff/erytem

Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis

Pilot Study to Evaluate Tea Tree Oil Gel for Facial Acne

K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

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