Acute folliculitis
Conditions
Interventions
Group 1: ilon® Salbe classic, max. 2 cm cord of ointment, twice daily, for max. 7 days
Group 2: Vaselin Salbe LAW, 100%, max. 2 cm cord of ointment, twice daily, for max. 7 days
Group 3: Polysept® Lös
Sponsors
Cesra Arzneimittel GmbH & Co.KG
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: A) Caucasian B) Age 18 – 80 years C) Gender: female or male D) Acute folliculitis E) Ability to take and transfer pictures of the respective skin area via mobile phone to the Investigator F) Actively cooperating to participate in the trial, to follow the instructions of the Investigator and to attend the agreed visits. G) Patient has signed the consent form after the nature of the trial was fully explained by the Investigator and understood by the patient.
Exclusion criteria
Exclusion criteria: A) Presence of skin lesions, e.g. open wounds or ulcers in the respective skin areas B) Presence of skin diseases other than acute folliculitis and interfering with study treatment C) Treatment with epidermal growth factor receptor (EGFR) inhibitors D) Topical use of any dermatological product (e.g. medications, medicinal products, cosmetic products) on the trial areas during the trial. E) Hyperthyreosis F) Any systemic or topical immunosuppressive therapy (e.g. corticosteroids) within 3 weeks prior to randomization. G) Congenital or acquired immunodeficiency H) Participation in any other trial within 30 days prior to randomization or during the trial. I) Contraindications to any component of the study medication. J) Known allergy or intolerance to any component of the study medication (cave iodine allergy). K) History of drug, alcohol or chemical abuse L) Other(s), considered as important by the Investigator (e.g. multiple naevi in trial area, important hair growth in trial area, pigmented skin impairing visual assessment etc.). M) Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total follicle lesion counts from Visit 1 (day 0) to the day of study completion (Visit 4 / day 7; Visit 3 / day 4-5 in case complete healing occurs prior to Visit 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| A) Change in total follicle lesion counts from Visit 1 (day 0) to Visit 2 (day 2-3) and to Visit 3 (day 4-5) B) Course of total follicle lesion counts from day 0 to day 7 on the basis of patient's daily photographic pictures C) Counts of follicle lesions differentiated to inflammatory, non-inflammatory, and total lesions on Visit 1 (day 0), Visit 2 (day 2-3), Visit 3 (day 4-5), and Visit 4 (day 7) D) Physician's and patient's Global Assessment on the basis of a VAS (visual analogue scale) (0-10) before treatment (Visit 1, day 0) and on Visits 2-4 E) Period to complete healing (determined based on physician's evaluation at each visit) F) Assessment of tolerability on the basis of a VAS (visual analogue scale) (0-10) by patient (daily) and physician (at final visit) G) rate and type of occurred Adverse Events | — |
Countries
Germany
Contacts
Public ContactHilde Huber
AKP GmbH
Outcome results
None listed