| 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.1.2 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 | 10040785 - Skin and subcutaneous tissue disorders |
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| 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 establish the therapeutic equivalence of topical treatment with clindamycin+tretinoin/Verisfield gel (Test product) and Acnatac®/Meda gel (Reference product) in the treatment of acne vulgaris by demonstrating that the two products are therapeutically equivalent and superior to the Placebo, through assessing the changes from Baseline in the facial inflammatory and non-inflammatory lesion counts at Week 12. |
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| E.2.2 | Secondary objectives of the trial |
• To compare the efficacy of topical treatment with clindamycin+tretinoin/Verisfield gel (Test product) against that of Acnatac®/Meda gel (Reference product) in terms of success of therapy using the IGA scale.
• To compare the safety and tolerability profile of topical treatment with clindamycin+tretinoin/Verisfield gel (Test product) versus that of Acnatac®/Meda gel (Reference product).
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Male or non-pregnant non-lactating female aged ≥ 12 and ≤ 40 years at the time of consent/assent.
• Subject has a clinical diagnosis of mild to severe facial acne vulgaris defined as Grade 2, 3, or 4 based on the IGA at Baseline.
• Subject must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face at Baseline.
• Subject has used the same type and brand of non-medicated make-up, cleanser or other non-medicated facial products and hair products for at least 14 days prior to Baseline and agrees to continue and not change his/her non-facial general skin care and hair care products and frequency of use for the entire study period.
• Subject must be willing and able to refrain from use of all other topical products applied to face (moisturizer, new brands of make-up, creams, lotions, powders or any topical product other than the assigned treatment to the treatment area and the study-supplied cleanser and sunscreen), all acne medications and antibiotics for acne present on the face during the 12-week treatment period.
• Subject, in the Investigator’s opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of facial acne vulgaris or otherwise impact the integrity of the study, or exposes the subject to an unacceptable risk by study participation.
• If FOCBP1,2, willingness to use an acceptable form of birth control during the study [i.e., must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of the IP]. FOCBP must have a negative urine pregnancy test (UPT)3 at Baseline.
• Subject and parent(s)/guardian (if applicable) are willing and able to apply the IP as directed, comprehend and comply with study instructions, and follow the requirements of the study (including availability on scheduled visit dates) for the duration of the study.
• Subject [and their parents(s)/guardian/legally authorized representative(s), as applicable] is (are) able to understand and willing to provide voluntary written informed assent/consent before any study-related procedure is performed.
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| E.4 | Principal exclusion criteria |
• Subject is pregnant, breastfeeding or is planning a pregnancy or breastfeed throughout the study period and for 30 days after the last administration of the IP.
• Subject has pustular and deep cystic nodular acne varieties (acne conglobata and acne fulminans), or other forms of acne (e.g., acne mechanica).
• Subject has Crohn’s disease, regional enteritis, ulcerative colitis or history of antibiotic-associated colitis.
• Subject has atopic dermatitis or a history of acute eczemas, rosacea and perioral dermatitis, and any skin condition that, in the Investigator’s opinion, could interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Subject has a personal history of skin cancer.
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), facial tattoos, or other facial attributes that could interfere, in the Investigator’s opinion, with diagnosis or assessment of acne vulgaris.
• Subject has any contraindication to clindamycin phosphate and tretinoin or history of hypersensitivity or allergy to tretinoin, retinoids, clindamycin or to any of the study medication excipients or lincomycin (see section 11.1).
• Subject has used for less than 3 months (90 days) prior to Baseline oestrogens or oral contraceptives; subjects treated with such agents 30 or more consecutive dates immediately prior to Baseline need not be excluded unless the subject expects to change dose, drug or discontinue this use during the study. If the subject had used hormonal birth control and had stopped, this should have occurred more than 3 months prior to Baseline.
• Subject has used antipruritics, including antihistamines within 24 hours prior to Baseline.
• Subject has used any of the following topical preparations or procedures on the face:
- within 1 month (30 days) prior to Baseline:
a. cryodestruction or chemodestruction
b. dermabrasion
c. photodynamic therapy including other light-based and laser therapies
d.acne surgery
e. intralesional steroids
f. x-ray therapy.
- within 2 weeks prior to Baseline:
a. topical steroids
b. topical retinoids (e.g., tazarotene, adapalene, and tretinoin)
c. topical acne treatments including, but not limited to, OTC acne cleansers, soaps, washes or treatments, benzoyl peroxide, antibiotics, azelaic acid, dapsone, sulfa based products, corticosteroids, and salicylic acid
d. topical anti-inflammatory agents
e. topical antibiotics
- at any time prior to Baseline:
a. other topical therapy which may materially affect the subject’s acne, in the Investigator’s opinion.
• Subject has used any of the following systemic medication:
- within 6 months prior to Baseline:
a. oral retinoids (e.g., Accutane®)
b. therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- within 3 months prior to Baseline:
a. hormonal therapy for acne management
- within 1 month prior to Baseline:
a. androgen receptor blockers (e.g., spironolactone, flutamide)
b. steroids (including intramuscular, intra-articular, and intralesional injections)
c. antibiotics
d. treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout)
e. anti-inflammatory agents
f. immunosuppressive drugs.
- within 2 weeks prior to Baseline:
a. neuromuscular blocking agents such as botulinum toxin type A (e.g., BOTOX, DYSPORT)
- at any time prior to Baseline:
a. other systemic therapy which may materially affect the subject’s acne, in the Investigator’s opinion.
• Subject with known evidence of lack of adherence to medications and/or lack of ability to follow physician’s recommendations (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the Investigator.
• Previous treatment with the Reference product.
• Subject engages in activities that involve excessive or prolonged exposure to sunlight, or is required to have considerable sun exposure due to occupation, or with inherent sensitivity to the sun, or is exposed or planned to be exposed to artificial tanning devices.
• Subject is planning surgery during the study.
• Subject currently receives treatment with any investigational drug/device/intervention or has received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before Baseline.
• Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the Investigator due to language problems or mental incapacity.
• Subject with close affiliation with the Investigator (i.e., family members) or study staff or subject who is involved in the planning and/or conduct of the study (applies to Investigator, study staff, and Sponsor).
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| E.5 End points |
| E.5.1 | Primary end point(s) |
• Percent change from Baseline to Week 12 in the facial inflammatory (papules and pustules) lesion count in each of the three treatment arms.
• Percent change from Baseline to Week 12 in the facial non-inflammatory (open and closed comedones) lesion count in each of the three treatment arms
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
• Proportions of participants receiving Test and Reference product who have achieved a clinical response of ‘success’ to therapy at Week 12 according to the IGA scale.
• Incidence and severity of treatment-emergent serious and non-serious topical and systemic AEs and adverse drug reactions (ADRs) in each of the treatment arms during the 12-week study period.
• Proportions of participants with application site reactions (i.e., erythema, dryness, burning/stinging, erosion, edema, pain and itching), overall and per type and severity of reaction, in each of the treatment arms during the 12-week study period.
• Proportions of participants with permanent treatment discontinuations, and reasons for discontinuation in each of the treatment arms during the 12-week study period
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
| 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 |
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| 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) | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| 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 | 10 |
| 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 | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| 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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| Last Visit Last Subject (LVLS) |
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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 | 3 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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