| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10000519 |
| E.1.2 | Term | Acne vulgaris |
| E.1.2 | System Organ Class | 100000018399 |
|
| 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 compare the early efficacy of Duac Combination Gel once daily (QD) to the
combination therapy of ADA QD and CLDM twice daily (BID) at Week 2. |
|
| E.2.2 | Secondary objectives of the trial |
To compare efficacy and Global Improvement of Duac Combination Gel QD to the
combination therapy of ADA 0.1% QD and CLDM 1% BID.
To evaluate safety and tolerability of Duac Combination Gel QD and the
combination therapy of ADA 0.1% QD and CLDM 1% BID. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subjects 12 to 45 years (inclusive) of age
2. Subjects must have both:
A) A minimum of 17 but not more than 60 inflammatory lesions (papules / pustules) on the face, including nasal lesions.
And
B) A minimum of 20 but not more than 150 non- inflammatory lesions (open / closed comedones) on the face, including nasal lesions.
3. An Investigator’s Static Global Assessment (ISGA: global assessment of severity by the investigator) score of 2 or greater at Baseline.
4. The ability to understand and give a written informed consent form (Written informed consent must be obtained also from the parent or guardian if the subject is under 20 years of age).
5. Females of childbearing potential and women who are less than 2 years from their last menses must agree to use the following contraception [Hatcher 2007(a); Hatcher 2007(b)]:
Abstinence;
Oral Contraceptive (either combined or progestogen alone), injectable progestogen, implants of levonorgestrel, or estrogenic vaginal ring (as long as the subject has been on treatment for more than 12 consecutive weeks prior to start of investigational product use);
Intrauterine device (IUD) or intrauterine system (IUS);
Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject;
Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
6. The ability and willingness to follow all study procedures and to visit all scheduled evaluation points.
Male and Female subjects |
|
| E.4 | Principal exclusion criteria |
1. Have any nodulo-cystic lesions at Baseline.
2. Are pregnant or breast-feeding.
3. Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, antibiotic-associated colitis or bloody diarrhea) or similar symptoms.
4. Have a medical history suggestive of an immunocompromised status.
5. 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., BPO, azelaic acid, resorcinol, salicylates etc.)
Abradants, facials, peels, masks containing glycolic or other acids
Washes, soaps, non-mild facial cleansers containing BPO, salicylic acid, or sulfacetamide sodium
Moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids (except additive agent)
Astringents and toner
6. Used 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 or laser peel, microdermabration, blue light treatment, etc.)
7. Used systemic retinoids within the previous 6 months or topical retinoids within 6 weeks prior to baseline.
8. 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).
9. Using any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
10. Plan to use medications that are reported to exacerbate acne (e.g., vitamin D, vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium, hydantoin, and phenobarbital).
11. Have a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening.
12. Have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
13. Used any investigational therapy within the previous 12 weeks, or plan to participate in another clinical study at the same time.
14. Participated in another Japanese clinical studies planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
15. Are employees of GlaxoSmithKline, an investigator, or contract research organization (CRO) involved in the study, or any immediate family member of an employee involved in the study.
16. Have other conditions that would put the subject at unacceptable risk for participation in the study. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The percent (%) change in total lesion counts from baseline to Weeks 2. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Baseline, Weeks 1,2,4,8, and 12 or end of study. |
|
| E.5.2 | Secondary end point(s) |
The percent (%) change in total lesion counts from baseline to Weeks 1, 4, 8, and 12 (or end of the study).
The percent (%) change in lesion counts (inflammatory and non-inflammatory) from baseline to Weeks 1, 2, 4, 8, and 12 (or end of the study).
The absolute change in lesion counts (total, inflammatory, and non-inflammatory) from baseline to Weeks 1, 2, 4, 8, and 12 (or end of the study).
The proportion of subjects who have a minimum 2-grade improvement in Investigator’s Static Global Assessment (ISGA) score from baseline to Weeks 1, 2, 4, 8, and 12 (or end of the study).
Adverse events (AEs) – nature, severity and frequency.
Local tolerability (erythema, dryness, peeling, itching, and burning/stinging) score over all study time points.
The proportion of subjects who have an ISGA score of 0 or 1 at Weeks 1, 2, 4, 8, and 12 (or end of the study).
The proportion of subjects who have a reduction in lesion counts (total lesions, inflammatory lesions or non- inflammatory lesions) of at least 50% from baseline to Weeks 1, 2, 4, 8, and 12 (end of the study).
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Weeks 1, 2, 4, 8 and 12 or end of study. |
|
| 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 | No |
| 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 | Yes |
| E.6.13.1 | Other scope of the trial description |
Compliance and adherence at Weeks 1, 2, 4, 8, and 12 (or end of the study).
The proportion of subjects who continue the therapy at Weeks 1, 2, 4, 8, and 12.
Patient preference at Weeks 1, 2, 4, 8 |
|
| 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 | No |
| E.8.1.3 | Single blind | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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