E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute folliculitis |
Akute Follikulitis |
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E.1.1.1 | Medical condition in easily understood language |
Acute inflammation of hair follicle |
Akute Entzündung der Haarfollikel |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the change in total folliculitis lesion counts from Visit 1 (day 1) to the day of study completion. |
Änderung in der Gesamtzahl an Follikulitisherden von Tag 1 zum Studienende |
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E.2.2 | Secondary objectives of the trial |
To assess: - Change of total folliculitis lesion counts from Visit 1 (day 1) to Visit 2 (day 7). - Counts of folliculitis lesions differentiated to purulent, inflammatory, healing and total lesions at Visit 1 (day 1), Visit 2 (day 7) and Visit 3 (day 14). - Physician´s and patient’s Global Assessment on the basis of a VAS (0-10) before treatment (Visit 1, day 1) and on Visits 2 and 3. - Period to healing |
- Änderung in der Gesamtzahl an Follikelherden von Visite 1 (Tag 1) zu Visite 2 (Tag 7) - Anzahl der Follikulitisherde differenziert nach „entzündlich“, „nicht-entzündlich“, „abheilend“ und Gesamtzahl bei Visite 1 (Tag 1), Visite 2 (Tag 7) und Visite 3 (Tag 14) - Allgemeine Beurteilung durch Arzt und Patient auf Basis einer VAS (0-10) vor Behandlung (Visite 1, Tag 1) und an den Visiten 2 und 3 - Dauer bis zur Abheilung |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Caucasian - Age 18 – 80 years - Gender: female or male - Acute folliculitis with 2 to 12 hair folliculitis lesions in a defined area of 5x5 cm - Actively cooperating to participate in the trial, to follow the instructions of the Investigator and to attend the agreed visits. - Patient has signed the consent form after the nature of the trial was fully explained by the Investigator and understood by the patient. - At least one evaluable photograph of the skin area to be treated has been taken at visit 1.
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E.4 | Principal exclusion criteria |
- Presence of skin lesions, e.g. open wounds or ulcers in the respective skin area - Presence of acne in the respective skin area - Presence of potential fungal or viral caused skin infections (e.g. Malassezia caused dermatitis) - Presence of skin diseases other than acute folliculitis and interfering with study treatment - Treatment with epidermal growth factor receptor (EGFR) inhibitors - Topical use of any dermatological product (e.g. medications, medicinal products, cosmetic products) on the trial areas during the trial. - Any systemic or topical immunosuppressive therapy (e.g. corticosteroids) within 3 weeks prior to randomization. - Congenital or acquired immunodeficiency - Participation in any other trial within 30 days prior to randomization or during the trial. - Contraindications to any component of the study medication. - Known allergy or intolerance to any component of the study medication - History of drug, alcohol or chemical abuse - 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.). - Pregnant or lactating females |
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E.5 End points |
E.5.1 | Primary end point(s) |
change in total folliculitis lesion counts from Visit 1 (day 1) to the day of study completion. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visit 1 (day 1) and day of study completion (Visit 3/day 14; Visit 2/day 7 in case complete healing occurs prior to Visit 3). |
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E.5.2 | Secondary end point(s) |
- Change of total folliculitis lesion counts from Visit 1 (day 1) to Visit 2 (day 7). - Counts of folliculitis lesions differentiated to purulent, inflammatory, healing and total lesions at Visit 1 (day 1), Visit 2 (day 7) and Visit 3 (day 14). - Physician´s and patient’s Global Assessment on the basis of a VAS (0-10) before treatment (Visit 1, day 1) and on Visits 2 and 3. - Period to healing
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Visit 1 (day1) - Visit 2 (day 7) - Visit 3 (day 14) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |