S50.81
Conditions
Interventions
Group 1: Abrasive wound model, intra-individual comparison of IMD A and B to untreated on both forearms
macro photos and measurement of skin hydration on a total of 3 wounds.
- Application of ointments twice daily for 14 days
- Covering of the abrasions with plasters until day 7
From 36 subjects in the
documentation using LC-OCT
- Application as in arm 1 twice daily for 14 days, including covering the wounds with plasters
Sponsors
HÄLSA Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: • Skin type I to III (according to Fitzpatrick et al., 1974) • Written informed consent to participate in the study • Willingness to receive abrasive wounds on the forearm • Willingness to discontinue the application of leave-on cosmetics (e.g. creams, lotions) and to avoid the use of detergents (e.g. soaps) in the test area throughout the course of the study and 3 days before the start of study • Willingness to avoid hard physical exercises (with heavy sweating), sauna, swimming and bathing during the test phase • Willingness to avoid extensive artificial as well as natural UV light on the test areas during the whole course of the study and for at least 3 months after the end of study • Willingness to avoid contact of the test area with water during the time of patch application (careful showering) • Uniform skin color and no erythema or dark pigmentation in the test area • Negative urine pregnancy test for sexually active women of child-bearing potential (WOCBP)1 at screening • WOCBP must be willing and able to use at least an acceptable method2 of birth control at least 3 months prior to screening and during the study. Specific inclusion criteria for arm 2: • Tightness, roughness, or a sensation of dryness inside the nose (both nostrils), as reported by the participant. The symptoms must not be attributed to active infection (e.g., bacterial rhinitis) or ongoing dermatologic conditions requiring separate treatment (e.g., atopic dermatitis, psoriasis) Specific inclusion criteria for arm 3: • Willingness to receive 3 additional abrasive wounds on the forearm.
Exclusion criteria
Exclusion criteria: • Active skin diseases, moles, tattoos, strong pigmentation and hairy skin in the test area or scars in the test areas • Psoriasis and/or lichen ruber and/or atopic dermatitis • History of keloids and hypertrophic scars • History of plaster sensitivity • Intake of drugs interfering with the immune system • Concomitant therapy with substances at doses affecting blood coagulation • Topical treatment of the test areas with drugs within 14 days prior to day 1 as well as during the study (moisturizers and sun protection are allowed until 3 days prior to day 1) • Any therapy (drug or non-drug) which might make it unsafe for the participant to participate in this study or interfere with the evaluation of the safety or efficacy of the IMDs (e.g. medication for diabetes) • Diabetes • Intensive UV-light exposure within two weeks before day 1 as well as during the study at the test areas • Removal of axillary lymph nodes • Allergy to the ingredients of the IMDs • Pregnancy or lactation • As per the investigator's discretion, any physical or mental condition which might make it unsafe for the participant to participate in this study or interfere with the evaluation of the safety or efficacy of the IMDs • Psychiatric conditions that might limit the participation in the study and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing • History of drug addiction or alcoholism in the past 3 years • Infectious diseases • Participants with expected poor compliance • As per the investigator's discretion, any reason that the participant should not participate in the study • Participation in a clinical study within the last 30 days prior to day 1 and during the study conduct • Employees of the study sites or of the sponsor company • Participants, who are inmates of psychiatric wards, prison or state institutions Specific exclusion criteria for arm 2: • Presence of symptoms or clinical signs consistent with an acute upper respiratory tract infection (e.g., common cold, viral rhinitis, or sinusitis) at day 1, including but not limited to nasal congestion or obstruction, acute onset of rhinorrhea (runny nose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Comparison of open wound area size (IMD A and B vs. untreated) as AUC of relative change up to day 15. - Method: Calibrated dermatoscope macro photos (1 image/area/time point), area calculation using software; AUC using trapezoidal rule | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: • To evaluate the wound healing properties of each IMD compared to the untreated as determined by skin barrier measurement (Tewameter) • To evaluate the wound healing properties of each IMD compared to untreated by visual wound healing assessment • To evaluate the skin hydration properties of each IMD compared to untreated (Corneometer) Secondary safety endpoints: • To evaluate the local cutaneous tolerability of each IMD by dermatological objective assessment (erythema, edema, scab) • To evaluate the local cutaneous tolerability of each IMD by subjective parameters (feeling of itching, burning, tension, pain) • To evaluate the overall global local tolerability of each IMD (including overall objective and subjective outcomes, and related adverse events (AEs)) • To evaluate participant satisfaction of each IMD by self-assessed questionnaire • To evaluate the safety of each IMD Explaratory objectives: • To evaluate the wound healing properties of IMD B compared to baseline in nasal cavity by skin barrier measurement (Aquaflux) (arm 1 only) • To evaluate wound healing properties on cellular level for each IMD compared to untreated in forearm wound area by LC-OCT (arm 2) | — |
Countries
Germany
Contacts
Public ContactKirstin Deuble-Bente
SGS proderm GmbH
Outcome results
None listed