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Components:
Adapalene, Benzoyl Peroxide
Method of action:
Antiacne
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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 2019.11.17

Name of the medicinal product

Adaben-Duo

Qualitative and quantitative composition

Adapalene; Benzoyl Peroxide

Therapeutic indications

The information provided in Therapeutic indications of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present

Adaben-Duo is indicated in adults and adolescents aged 9 years and over.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Adaben-Duo should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes and lips.

If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether.

The duration of treatment should be determined by the Doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.

The safety and effectiveness of Adaben-Duo have not been studied in children below 9 years of age.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Adaben-Duo Gel should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned.

Adaben-Duo should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water.

This product contains propylene glycol (E1520) that may cause skin irritation.

If a reaction suggesting sensitivity to any component of the formula occurs, the use of Adaben-Duo should be discontinued.

Excessive exposure to sunlight or UV radiation should be avoided.

Adaben-Duo should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Not relevant.

Undesirable effects

The information provided in Undesirable effects of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Adaben-Duo may cause the following adverse reactions at the site of application:

System Organ Class (MedDra)

Frequency

Adverse Drug Reaction

Eye disorders

Not known (cannot be estimated from the available data)*

Eyelid oedema

Immune system

Not known (cannot be estimated from the available data)*

Anaphylactic reaction

Respiratory, thoracic and mediastinal disorders

Not known (cannot be estimated from the available data)*

Throat tightness, dyspnoea

Skin and subcutaneous tissue disorders

Common (>1/100 to <1/10)

Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation (scaling)

Uncommon (>1/1000 to <1/100)

Pruritus, sunburn

Not known (cannot be estimated from the available data)*

Allergic contact dermatitis, swelling face, pain of skin (stinging pain), blisters (vesicles), skin discolouration, (hyperpigmentation and hypopigmentation), urticaria.

*Post marketing surveillance data

If skin irritation appears after application of Adaben-Duo, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning and pain of skin (stinging pain) peaking during the first week and then subsiding spontaneously.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Adaben-Duo is for once-daily cutaneous use only.

In case of accidental ingestion, appropriate symptomatic measures should be taken.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Anti-Acne Preparations for Topical Use, D10AD Retinoids for topical use in acne;

ATC code: D10AD53

Mechanism of action and Pharmacodynamic effects:

Adaben-Duo combines two active substances, which act through different, but complementary, mechanisms of action.

- Adapalene: Adapalene is a chemically stable, naphthoic acid derivative with retinoid-like activity. Biochemical and pharmacological profile studies have demonstrated that adapalene acts in the pathology of Acne vulgaris: it is a potent modulator of cellular differentiation and keratinisation and it has anti-inflammatory properties. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors. Current evidence suggests that topical adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Adapalene inhibits the chemotactic (directional) and chemokinetic (random) responses of human polymorphonuclear leucocytes in in vitro assay models; it also inhibits the metabolism of arachidonic acid to inflammatory mediators. In vitro studies have shown inhibition of the AP-1 factors and the inhibition of the expression of toll like receptors 2. This profile suggests that the cell mediated inflammatory component of acne is reduced by adapalene.

- Benzoyl peroxide: Benzoyl peroxide has been shown to have antimicrobial activity; particularly against P. acnes, which is abnormally present in the acne-affected pilosebaceous unit. Additionally benzoyl peroxide has demonstrated exfoliative and keratolytic activities. Benzoyl peroxide is also sebostatic, counteracting the excessive sebum production associated with acne.

Clinical efficacy of Adaben-Duo in patients aged 12 years and older:

The safety and efficacy of Adaben-Duo applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing Adaben-Duo to its individual active components, adapalene and benzoyl peroxide, and to the gel vehicle in acne patients. A total of 2185 patients were enrolled in Study 1 and Study 2. The distribution of patients in the two studies was approximately 49% male and 51% female, 12 years of age or older (mean age: 18.3 years; range 12 - 50), presenting 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions at baseline. The patients treated the face and other acne affected areas as needed once daily in the evening.

The efficacy criteria were:

(1) Success rate, percentage of patients rated 'Clear' and 'Almost Clear' at Week 12 based on the Investigator's Global Assessment (IGA);

(2) Change and Percent Change from baseline at Week 12 in

- Inflammatory lesion counts

- Non-inflammatory lesion counts

- Total lesion count

The efficacy results are presented for each study in Table 1 and combined results in Table 2. Adaben-Duo was shown to be more effective compared to its monads and gel vehicle in both studies. Overall, the net beneficial effect (active minus vehicle) obtained from Adaben-Duo was greater than the sum of the net benefits obtained from the individual components, thus indicating a potentiation of the therapeutic activities of these substances when used in a fixed-dose combination. An early treatment effect of Adaben-Duo was consistently observed in Study 1 and Study 2 for Inflammatory Lesions at Week 1 of treatment. Noninflammatory lesions (open and closed comedones) noticeably responded between the first and fourth week of treatment. The benefit on nodules in acne has not been established.

Table 1 Clinical efficacy in two comparative trials

Study 1

Study 1

Week 12 LOCF; ITT

Adapalene+BPO

N=149

Adapalene

N=148

BPO

N=149

Vehicle

N=71

Success (Clear, Almost Clear)

41 (27.5%)

23 (15.5%)

p=0.008

23 (15.4%)

p=0.003

7 (9.9%)

p=0.002

Median Reduction (% Reduction) in

Inflammatory Lesion Count

17 (62.8 %)

13 (45.7 %)

p<0.001

13 (43.6 %)

p<0.001

11 (37.8 %)

p<0.001

Noninflammatory Lesion Count

22 (51.2 %)

17 (33.3 %)

p<0.001

16 (36.4 %)

p<0.001

14 (37.5 %)

p<0.001

Total lesion Count

40 (51.0 %)

29 (35.4 %)

p<0.001

27 (35.6 %

p<0.001

26 (31.0 %)

p<0.001

Study 2

Study 2

Week 12 LOCF; ITT

Adapalene+BPO

N=415

Adapalene

N=420

BPO

N=415

Vehicle

N=418

Success (Clear, Almost Clear)

125 (30.1%)

83 (19.8%)

p<0.001

92 (22.2%)

p=0.006

47 (11.3%)

p<0.001

Median Reduction (% Reduction) in

Inflammatory Lesion Count

16 (62.1 %)

14 (50.0 %)

p<0.001

16 (55.6 %)

p=0.068

10 (34.3 %)

p<0.001

Noninflammatory Lesion Count

24 (53.8 %)

22 (49.1 %)

p=0.048

20 (44.1 %)

p<0.001

14 (29.5 %)

p<0.001

Total Lesion Count

45 (56.3 %)

39 (46.9 %)

p=0.002

38 (48.1 %)

p<0.001

24 (28.0 %)

p<0.001

Table 2 Clinical efficacy in combined comparative trials

Adapalene+BPO

N=564

Adapalene

N=568

BPO

N=564

Gel Vehicle

N=489

Success (Clear, Almost Clear)

166 (29.4%)

106 (18.7%)

115 (20.4%)

54 (11.1%)

Median Reduction (% Reduction) in

Inflammatory Lesion Count

16.0 (62.1)

14.0 (50.0)

15.0(54.0)

10.0 (35.0)

Noninflammatory Lesion Count

23.5 (52.8)

21.0 (45.0)

19.0 (42.5)

14.0 (30.7)

Total Lesion Count

41.0 (54.8)

34.0 (44.0)

33.0 (44.9)

23.0 (29.1)

Clinical efficacy of Adaben-Duo in children 9 to 11 years old

During a paediatric clinical trial, 285 children with acne vulgaris, aged 9 - 11 years (53% of the subjects were 11 years old, 33% were 10 years old and 14% were 9 years old) with a score of 3 (moderate) on the IGA scale and a minimum of 20 but not more than 100 total lesions (Non-inflammatory and/or Inflammatory) on the face (including the nose) at baseline were treated with Adaben-Duo Gel once daily for 12 weeks.

The study concludes that the efficacy and safety profiles of Adaben-Duo Gel in the treatment of facial acne in this specific younger age group are consistent with results of other pivotal studies in subjects with acne vulgaris aged 12 years and older showing significant efficacy with an acceptable tolerability. A sustained early treatment effect of Adaben-Duo Gel compared to Gel Vehicle was consistently observed for all Lesions (Inflammatory, Non-Inflammatory, and Total) at Week 1 and continuing to Week 12.

Study 3

Week 12 LOCF; ITT

Adapalene + BPO

N=142

Vehicle Gel

N=143

Success (Clear, Almost Clear)

67 (47.2%)

22 (15.4%)

Median Reduction (% Reduction) in

Inflammatory Lesion Count

6 (62.5%)

1 (11.5%)

Noninflammatory Lesion Count

19 (67.6%)

5 (13.2%)

Total Lesion Count

26 (66.9%)

(18.4%)

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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The pharmacokinetic (PK) properties of Adaben-Duo are similar to the PK profile of Adapalene 0.1% gel alone.

In a 30-day clinical PK study, conducted in patients with acne who were tested with either the fixed-combination gel or with an adapalene 0.1% matched formula under maximised conditions (with application of 2 g gel per day), adapalene was not quantifiable in the majority of plasma samples (limit of quantification 0.1 ng/ml). Low levels of adapalene (Cmax between 0.1 and 0.2 ng/ml) were measured in two blood samples taken from the subjects treated with Adaben-Duo and in three samples from the subjects treated with Adapalene 0.1% Gel. The highest adapalene AUC 0-24h determined in the fixed-combination group was 1.99 ng.h/ml.

These results are comparable to those obtained in previous clinical PK studies on various Adapalene 0.1% formulations, where systemic exposure to adapalene was consistently low.

The percutaneous penetration of benzoyl peroxide is low; when applied on the skin, it is completely converted into benzoic acid which is rapidly eliminated.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Anti-Acne Preparations for Topical Use, D10AD Retinoids for topical use in acne

Incompatibilities

The information provided in Incompatibilities of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Adaben-Duo is based on data of another medicine with exactly the same composition as the Adaben-Duo of the medicine (Adapalene, Benzoyl Peroxide). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Adaben-Duo directly from the package or from the pharmacist at the pharmacy.
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No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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