007 PH Skinoren e-Brochure

Azelaic acid



Skinoren ®

has found a


new home at

















Reveal the real you

®
Skinoren - an acne treatment Azelaic acid

with a triple-action formula 1-3 Skinoren ®












ANTI-KERATINIZING
ACTION


Blocked & infected Blocked pores (comedones)
pilosebaceous unit causes which you can see as
spots (pimples & papules) blackheads & whiteheads



Hair may break

Bacteria called
C. acnes may infect Inflammation develops in
blocked pilosebaceous unit nearby skin






ANTI-MICROBIAL ANTI-INFLAMMATORY
ACTION ACTION











References: 1. Zeichner Practical Dermatology March 2013. Available from:
practicaldermatology.com/pdfs/pd0313_ClinicalFocus.pdf. Accessed January 2019;
2. Sieber MA and Hegel JK. Skin Pharmacol Physiol 2014;27:9–17;
3. Skinoren® Product Information (Philippines).

Skinoren has comparable efficacy with Azelaic acid
®
Adapalene with significantly less dryness Skinoren ®

and scaling 1









54 Skinoren® 9 months
®
®
48 Skinoren® 3 months Tolerability of Skinoren 15% gel compared with
®
Inflammatory lesions 1 Mean 30 100%
adapalene gel in female adult acne
1
42
Adapalene 9 months
36
24
18
12 80%
6
0 6 12 18 24 30 36 60%
Time (weeks) Proportion of patients


54 Skinoren® 9 months 40%
®
48 Skinoren® 3 months
®
42 Adapalene 9 months 20%
Total lesions 1 Mean 30 0% Erythema Skinoren® ® Scaling Stinging/burning Pruritis
36

24
Adapalene
18
Dryness
12
6
0 6 12 18 24 30 36
Time (weeks)







Reference: 1. Thielitz A, et al. J Eur Acad Dermatol Venereol 2015;29(4):789–796.

®
Skinoren has comparable efficacy Azelaic acid

with other topical preparations 1 Skinoren ®










Skinoren ® vs BPO 1 Skinoren ® vs tretinoin 2 Skinoren ® vs clindamycin 1






0
0 Skinoren® 60 Skinoren® -20 Skinoren®
Median reduction of facial Papules and pustules -40 BPO (n=175) Total lesion count 40 Trentinoin Median reduction of facial Papules and pustules -40 Clindamycin
50
(n=176)
(n=114)
(n=143)
-20
0.05% (n=146)
1% (n=115)
30
-60
-60
20
-80
-80
-100 10 -100
0
0 1 2 3 4 0 1 2 3 4 5 6 0 1 2 3 4
Time (months) Time (months) Time (months)


70% median reduction of 71% reduction of inflamed lesion vs.
papules and pustules Reduction in total lesion count 63% in the clindamycin group










BPO, benzoyl peroxide
References: 1. Gollnick HP, et al. J Dtsch Dermatol Ges 2004;2:841–847.
2. Katsambas A, et al. Acta Derm Venerol 1989;Suppl 143:35–39

Tolerability of Skinoren versus Azelaic acid
®

other topical preparations Skinoren ®








®
Patients treated with Skinoren showed less Patients treated with Skinoren showed less
®
frequent dryness, redness/irritation and scaling frequent burning, erythema and scaling than
than those treated with BPO 1 those treated with tretinoin 2





35% BPO 5% (N=176) 35% Tretinoin 0.05% (N=146)
®
®
Skinoren® (N=176) Skinoren® (N=143)
30% 30%
25% 25%
Frequency (%) 20% Frequency (%) 20%



15%
15%
10% 10%


5% 5%

0% 0%
Dry skin Redness/ Scaling Burning Itching Burning Erythema Scaling
Irritation

Randomized, blinded comparative trials Double-blind study
Adapted from Gollnick HP, et al. J Dtsch Dermatol Ges 2004;2:841–847. Adapted from Katsambas A, et al. Acta Derm Venerol 1989;Suppl 143:35–39.






BPO, benzoyl peroxide
References: 1. Gollnick HP, et al. J Dtsch Dermatol Ges 2004;2:841–847.
2. Katsambas A, et al. Acta Derm Venerol 1989;Suppl 143:35–39

®
Skinoren is a recommended option Azelaic acid

across severities of acne Skinoren ®










• Topical and systemic treatments target the underlying causes of acne

and are implemented based on the severity of acne 1,2



®
• Skinoren is included in guideline recommendations from mild to severe
acne and as a maintenance therapy 1,2































BPO, benzoyl peroxide
References1. EDF. S3-Guideline for the treatment of acne. 2016;
2. Thiboutot DM, et al. J Am Acad Dermatol 2018;78:S1–23.

Azelaic acid
Skinoren ® is a treatment that fits in with their ®

lifestyle and suitable for long-term use 1-2 Skinoren












Anti-
microbial

Can be used while
wearing make-up 3**


















®
Skinoren inhibits the growth of No need to avoid
cutaneous bacteria but does not sun exposure 1,4

cause bacterial resistance 1–2







References: 1. Sieber MA and Hegel JK. Skin Pharmacol Physiol 2014;27(Suppl 1):9–17;
2. Maple PA, et al. J Antimicrob Chemother 1992;29(6):661–668.
3. . Dreno Bet al. J Eur Acad Dermatol Venereol 2013;27:1063-1070..
4. Gollnick HP, et al. J Dtsch Dermatol Ges 2004;2:841–847.
** No adequate well controlled studies available.

Reveal the real you with Skinoren ® Azelaic acid

Skinoren ®












®
 Skinoren is for women with mild-to-
moderate inflammatory acne 1
 Acne therapy with comparable success

rates to other topical preparations and an

acceptable safety profile 2-3
 Triple action formula designed to meet
4
the needs of adult women with acne

 Suitable for long-term treatment 3,5

 Fits in with their lifestyles, without the need
to avoid make-up or sun exposure 3-4,6

 May be used during pregnancy, following

physician consultation 1,6-7










References: 1. Skinoren® Product Information (Philippines) , 2. Kotsombos A et al. Acta Derm Venereal Suppl
(Stockh) 1989;143:35-39. , 3. Gollnick HP et of. J Dtsch Dermotol Ges 2004;2:841-847, 4. Sieber MA & Hegel JK.
Skin Pharmacol Physiol 2014;27 Suppl 1:9-17, 5. Thiboutot D. J Drugs Dermotol 2008;7:13-16 , 6. Dreno Bet al. J
Eur Acad Dermatol Venereol 2013;27:1063-1070. , 7. Kong YL & Tey HL. Drugs 2013;73:779-787.

Azelaic acid

Skinoren ®






Abbreviated Product Information

COMPOSITION: 1 g Azelaic acid (Skinoren®) gel contains 150 mg (15 %) azelaic acid.
INDICATIONS: Treatment of acne vulgaris, papulopustular rosacea. POSOLOGY AND METHOD
OF ADMINISTRATION: Cutaneous use. Azelaic acid (Skinoren®) gel should be applied to the
affected areas of skin twice a day (morning and evening) and rubbed in gently. Approximately
0.5 g = 2.5 cm (1 inch) of gel is sufficient for the entire facial area. It is important to continue to
use Azelaic acid (Skinoren®) gel regularly over the entire period of treatment. The duration of
use of Azelaic acid (Skinoren®) gel can vary from patient to patient and also depends on the
severity of the skin disorder. In general, a distinct improvement becomes apparent after about
4 weeks. To obtain the best results, Azelaic acid (Skinoren®) gel should be used continuously
over several months. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any
of the excipients of the gel. UNDESIRABLE EFFECTS: Pruritus, burning, and pain at the
application site are very common adverse events associated with topical administration of
Skinoren®. Hypersensitivity, skin irritation, urticaria, and worsening of asthma have also been
reported. SHELF LIFE: 36 months. SPECIAL PRECAUTIONS FOR STORAGE: Store at temperatures
not exceeding 30°C.

Skinoren® 150mg/g Gel API version JUN2019










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