Healthy volunteer trial to investigate the effects of IDP-110 Gel compared to two marketed products containing cindamycin-benzoyl peroxide on epidermal functions
Conditions
Interventions
Product Name: IDP-110 Gel (clindamycin 1 % / benzoyl peroxide 2.5 %)
Pharmaceutical Form: Gel
INN or Proposed INN: Clindamycin
CAS Number: 24729-96-2
Current Sponsor code: IDP-110 Gel (clindamycin 1 %
Sponsors
Arcutis Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in the study: • men and women aged 18 years or older; • healthy skin as determined by clinical examination on which reddening can be easily recognized in the area of the test fields; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide; • written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are to be excluded from the study when one or more of the following conditions are met: • acne, suntan, eczema, hyperpigmentation or tattoos in the test fields; • dark-skinned persons whose skin color prevents ready assessment of skin reactions; • evidence of drug or alcohol abuse in the past one year; • pregnancy or nursing; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in the treatment phase of another clinical study during the study or within the last four weeks prior to the first administration of investigational drug in this study; • known allergic reactions to components of the study preparations; • treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the beginning of the study or during the study (e.g. antihistamines or glucocorticosteroids); • contraindications according to summary of product characteristics (SmPC) of the test products; • in the opinion of the investigator performing the initial examination, the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; • subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): The primary variables encompass • skin moisture using corneometry • skin redness using chromametry • barrier impairment using TEWL • erythema and dryness assessments using clinical scoring. ;Main Objective: Investigation of the effects of IDP-110 Gel compared to two marketed products containing cindamycin-benzoyl peroxide on epidermal functions. | — |
Countries
Germany
Outcome results
None listed