Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Evaluation of Efficacy at 2 Weeks of Duac® Fixed Dose Combination Gel in Treatment of Facial Acne Vulgaris in Japanese Subjects
Brief Summary: This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene \[ADA\] and clindamycin \[CLDM\])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.


Options:
A: Inclusion Criteria:

* A clinical diagnosis of acne vulgaris with facial involvement.
* A minimum of 20 but not more than 50 inflammatory lesions
* A minimum of 30 but not more than 100 noninflammatory lesions
* A score of 3 (Moderate) on the Investigator's Global Assessment Scale
B: Inclusion Criteria:

* Documented diagnosis of acne vulgaris.
* Lesion count: 20 to 50 inflammatory (papules and pustules) and 30 to 100 noninflammatory (open and closed - comedones) facial lesions excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at baseline.
* Investigator Static Global Assessment of 3 or 4 at Baseline.

Exclusion Criteria:

* Clinically relevant finding at baseline or medical history of severe systemic diseases or diseases of the facial skin, other than acne vulgaris.
* Subjects with cystic acne lesions.
* Facial hair that may obscure the accurate assessment of acne grade.
* History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a history of antibiotic-associated colitis) or similar symptoms.
* Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of increased phototoxicity.
* Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
* Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, and glycolic acid) within the past 2 weeks.
* Use of topical antibiotics on the face within the past 2 weeks or systemic antibiotics within the past 4 weeks.
* Use of topical corticosteroids on the face or systemic corticosteroids within the past 2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional (other than for facial acne lesions) steroids is acceptable.
* Use of systemic retinoids, such as Isotretinoin, within the past 6 months.
* Concomitant use of the following types of facial products: astringents, toners, abradants, hair removal wax, facials, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β hydroxy acids.
* Concomitant use of medications that are reported to exacerbate acne, (eg, vitamins such as vitamin D, vitamin A, vitamins B2, B6, B12; haloperidol, halogens such as iodide and bromide, lithium, cyclosporine, psoralen, sirolimus, imatinib, aripiprazole, isoniazid, valproate acid, hydantoin, and phenobarbital) as these may impact efficacy assessments. Iron supplements and folate are acceptable.
* Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
* Known hypersensitivity or previous allergic reaction to any component(s) or excipient(s) of the study products.
* Use of any investigational medications or treatments within the past 4 weeks.
* Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product and have not been prescribed for the treatment of Acne Vulgaris. Subjects that have been treated with estrogens, as described above, androgens, or anti androgenic agents for more than 12 consecutive weeks prior to start of study treatment are allowed to enroll as long as they do not expect to change dose, medication, or discontinue use during the study.
* Evidence of recent alcohol or drug abuse (in the opinion of the investigator).
* Live in the same household as currently enrolled subjects.
* Employee of the investigator, a clinical research organization, or Stiefel Laboratories who is involved in the study or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.
C: Inclusion Criteria:

1. Male or female, who is 12 years of age or older at Screening visit.
2. Clinical diagnosis of acne vulgaris with facial involvement.
3. An IGA of Moderate (3) or Severe (4) at Baseline visit.
4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

1. More than 2 acne nodules on the face at Baseline visit.
2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
6. Use of hormonal contraceptives solely for control of acne.
D: Inclusion Criteria:

* Male and female subjects between 12 to 45 years of age, inclusive.
* Subjects must have had both: (a) A minimum of 17 but not more than 60 ILs (papules / pustules) on the face, including nasal lesions; (b) A minimum of 20 but not more than 150 non-ILs (open / closed comedones) on the face, including nasal lesions.
* Subjects who have an ISGA score of 2 or greater at Baseline.
* Female subjects of childbearing potential and women who are less than 2 years from their last menses must agree to use contraception
* Subjects who are willing and able to follow all study procedures and to visit all scheduled evaluation points.
* Subjects who have ability to understand and give a written informed consent form (written informed consent must be obtained also from the parent or guardian if the participant is under 20 years of age).

Exclusion Criteria:

* Subjects who have any nodulo-cystic lesions at Baseline.
* Female subjects who are pregnant or who are breast-feeding.
* Subjects who have a history or presence of regional enteritis, inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, antibiotic-associated colitis or bloody diarrhoea) or similar symptoms.
* Subjects who used any of the following agents within 2 weeks prior to Baseline: topical antibiotics on the face or systemic antibiotics; topical anti-acne medications (e.g. Benzoyl peroxide, azelaic acid, resorcinol, salicylates etc.); abradants, facials, peels, masks containing glycolic or other acids; washes, soaps, non mild facial cleansers containing benzoyl peroxide, salicylic acid or sulfacetamide sodium; moisturizers containing retinol, salicylic acid or alpha or beta-hydroxy acids (except additive agent); astringents and toner.
* Subjects who used any of the following agents on the face or performed the following procedure within 4 weeks prior to baseline: topical corticosteroids applied onto face (use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable); facial procedure (such as chemical and laser peel, microdermabration, blue light treatment, etc.).
* Subjects who used systemic retinoids within the previous 6 months or topical retinoids within 6 weeks prior to Baseline.
* Subjects who received treatment with estrogens, androgens or anti-androgenic agents within the previous 12 weeks (subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug or discontinue use during the study).
* Subjects who are using any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
* Subjects who plan to use medications that are reported to exacerbate acne (such as vitamin D and vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium, hydantoin and Phenobarbital).
* Subjects who have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
* Subjects who have used investigate therapy within the previous 12 weeks or plan to participate in another clinical study at the same time.
* Subjects who participated in another Japanese clinical study planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
* Subjects with a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening.
* Subjects who have medical history suggestive of an immunocompromized status.
* Subjects who are employees of a GlaxoSmithKline, an investigator or clinical research organization involved in the study or any immediate family member of an employee involved in the study.
* Subjects who have any other condition that would put the subject at unacceptable risk for participation in the study.

Answer: D