Investigation of the effectiveness, tolerability and safety of ilon® Salbe classic in the treatment of acute inflammation of the hair follicle (folliculitis) Prospective, open, randomized, placebo-/comparator controlled multicenter trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 70
Study Overview
Brief Summary
The primary efficacy endpoint in this study was the change in total follicle lesion counts from Visit 1 (Day 0) to the day of study completion (Final Visit). In subjects with evaluable photographic documentation of the affected skin area at Day 0 and the Final Visit, there was a mean reduction of follicle counts in the active treatment groups (ISC: -0.9±5.25; comparator: -1.3±5.86), while during placebo treatment follicle counts increased (0.4±3.83). Concerning the secondary endpoints, ISC showed statistically significant superiority over placebo for the evolution of the lesions during the course of the study (p=0.017), the responder rate (improvement of at least one count after the end of the study, p=0.032), and the subjective efficacy assessment by patients (p=0.029). All study medications were generally well tolerated. The number of adverse events was low with no relevant differences between the treatment groups. It can be concluded from this study the ilon® Salbe classic is an effective and safe option for the treatment of folliculitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
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
- •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