E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
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 |
The objectives of this study are to assess the efficacy and safety of DFD-03 Lotion in comparison to Vehicle Lotion in patients with acne vulgaris after 12 weeks of topical treatment. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject understands the study procedures, is willing to comply with the study procedures and required visits and agrees to participate by giving written informed consent. Subjects under the legal age of consent (i.e. < 18 years) must provide written assent and must have the written informed consent of both parents or their legal guardian.
2. Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study.
3. Male and female subjects aged 12 – 65 years (the latter exclusively).
4. Female subjects must be having regular menstrual periods at the Baseline Visit (as reported by the subject), exception: subjects using oral contraceptives that preclude regular menstrual periods, pre-menarcheal, menopausal or hysterectomized subjects.
5. A clinical diagnosis of facial acne vulgaris with an Investigator’s Global Assessment (IGA) score of 3 or 4 at Baseline.
6. Inflammatory lesion count (papules and pustules) of at least 20 on the face, including the nose, at Baseline.
7. Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face, including the nose, at Baseline.
8. No more than 2 nodulocystic lesions on the face, including the nose, at Baseline.
9. Females, regardless of childbearing potential:
a. Must have a negative urine pregnancy test at Baseline. Test must have a sensitivity of at least 25 mIU/ml for hCG.
b. If sexually active, 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.
Acceptable methods of birth control include:
• hormonal methods* (implants, injectables, combined oral contraceptives but no mini pills) or intrauterine device in use ≥ 90 days prior to Baseline; or
• partner has had a vasectomy at least 90 days prior to Baseline; or
• sexual abstinence
*Hormonal methods: If on hormonal contraceptives, must have been on the same hormonal contraceptive product for 3 months (90 days) prior to Baseline and continued on same method and dose throughout the duration of the study. If subject had used hormonal birth control and had stopped, this should have occurred more than 6 months prior to Baseline.
Exception: Sexually inactive female subjects are not required to practice a reliable method of contraception and may be enrolled at the investigator’s discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study.
10. Subjects agree not to use any product on the face during the entire course of study except for non-comedogenic study-provided sunscreen/moisturizer and non-comedogenic make-up as instructed by the investigator.
11. Subjects must be willing to comply with sun avoidance measures for the face including use of sunscreens and/or hats, have limited sun exposure time and have no tanning bed use.
12. Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse). Subjects are eligible if:
Systolic BP <140 and >100
Diastolic BP <90 and >50
Pulse 50 – 90 bpm inclusive
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E.4 | Principal exclusion criteria |
1. Females who are pregnant or lactating or planning to become pregnant during the study period.
2. Treatment with the following products:
a. Topical acne treatments (retinoids, antibiotics, benzoyl peroxide, azelaic acid, resorcinol, salicylates, α-hydroxy/glycolic acid) or other topical facial medication (antifungals, steroids, anti-inflammatory) on the treatment area in the 14 days prior to the Baseline Visit including prescription and non-prescription products.
b. Systemic corticosteroids, systemic antibacterials, systemic acne treatments, photosensitizing agents (thiazides, phenothiazines), spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit.
c. Systemic retinoid (including high dose vitamin A >10,000 units per day) in the 180 days prior to the Baseline Visit.
d. Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in 30 days prior to Baseline Visit.
e. Treatment with a medication that would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
f. Treatment with an investigational product or device in the 30 days prior to the Baseline Visit.
3. Known hypersensitivity to retinoids or tazarotene or any of the other ingredients of these products.
4. Subjects who are photosensitive.
5. Presence of any facial skin disease or condition including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema at Baseline, squamous cell carcinoma and other skin malignacies, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition that would interfere with the study or place the subject at unacceptable risk.
6. Excessive facial hair (i.e. heavy beard or moustache), facial tattoos or facial disfigurement that would interfere with study assessments.
7. Subjects with a serious and/or chronic medical condition (other than well controlled hypertension) like chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions (other than controlled diabetes) or any other disease that in the opinion of the investigator would interfere with the study or place the subject at unacceptable risk.
8. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year prior to the Baseline Visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Absolute Change from Baseline in inflammatory lesion counts at Week 12
2. Absolute Change from Baseline in non-inflammatory lesion counts at Week 12
3. Proportion of subjects achieving success at Week 12 with success defined as a score of “clear” or “almost clear” (IGA Score of 0 or 1) and a two or more grade (IGA) improvement from Baseline.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 (baseline) and day 84 +/- 5 days. |
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E.5.2 | Secondary end point(s) |
1. Proportion of patients with a 2 grade reduction in IGA scores from baseline
2. Percent change in inflammatory and non-inflammatory lesion counts from Baseline to Week 12
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 (baseline) and day 84 +/- 5 days. |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |