Subjects with facial acne MedDRA version: 13.1 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Acanya® Gel
Product Name: Acanya® Gel
Pharmaceutical Form: Gel
INN or Proposed INN: CLINDAMYCIN
CAS Number: 18323449
Concentration unit: % percent
Concentration type: equal
Concentration
Sponsors
Dow Pharmaceutical Sciences, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •men and women aged 16 years and older with mild to moderate acne symmetrical in appearance on both sides of the face; •Fitzpatrick skin phototypes of I, II or III; •subjects with facial acne inflammatory lesions (papules, pustules, and up to two nodules) count no less than 10 in the whole face (lesions on the nose are excluded in this count); •subjects with facial acne non-inflammatory lesions (open or closed comedones) count no less than 10 in the whole face (comedones on the nose are excluded in this count); •the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial; •female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; •written and verbal informed consent has been obtained by the subject and the parents or legal guardian (as applicable). Are the trial subjects under 18? yes 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: •suntan, hyperpigmentation or tattoos on the face; •subject intended to use a tanning booth or sunbath during the trial; •dark-skinned persons whose skin color prevents ready assessment of skin reactions; •symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before and during the trial; •participation in the treatment phase of another clinical trial within the last four weeks prior to the first administration of investigational drug in this clinical trial; •any dermatological conditions on the face that could interfere with clinical evaluations such as scarring, acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, etc.; •any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or made evaluations and lesion count inconclusive; •subjects with a facial beard or mustache that could interfere with the trial assessments; •subjects with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis; •treatment with antiperistaltic agents such as opiates and diphenoxylate with atropine within four weeks prior to the first administration of investigational drug in this trial and during the trial; •treatment with neuromuscular blocking agents within four weeks prior to the first administration of investigational drug in this trial and during the trial; •treatment for any type of cancer within the last 6 months; •subject uses medications and/or vitamins during the trial which were reported to exacerbate acne (azothiaprim, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, systemic or mid-to super-high potency corticosteroids, phenytoin and phenobarbital); •concomitant use of potentially irritating over-the-counter products that contained ingredients such as benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids; •subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications: Topical astringents and abrasives 1 week Cleansers and soaps containing antimicrobials 1 week Non-acceptable moisturizers or sunscreens 1 week Antibiotics on the face or other areas with acne 4 weeks Other topical anti-acne drugs 4 weeks Anti-inflammatories and corticosteroids 4 weeks Topical retinoids, including retinol 4 weeks; •subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections) 4 weeks Antibiotics 4 weeks Other systemic acne treatments 4 weeks (excluding systemic retinoids); •known allergic reactions to components of the investigational product/s; •contraindications according to summary of product characteristics (SmPC) of the IMPs; •evidence of drug or alcohol abuse; •pregnancy or nursing; •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the clinical trial, e.g. due to probable noncompliance or in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): ;Main Objective: The main objective is to assess the irritant potential of Acanya® Gel compared to Epiduo® Gel on acneic skin;Secondary Objective: Secondary objectives are to assess the skin moisture and barrier impairment after treatment with Acanya® Gel compared to Epiduo® Gel, self-assessments of dryness and burning/stinging and subject satisfaction. | — |
Countries
Germany
Outcome results
None listed