Multicentric, Parallel, Randomized, Double Blind Study Under Dermatological Control to Evaluate the Anti-acne Efficacy of a Dermo-cosmetic Product (Fla 688977 33) Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer (Hydréane légère, Cosmétique Active International) During a 12-week Application Period in Male and Female Subjects Presenting With Mild to Moderate Acne

Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment
Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject & inter subject comparisons

Start Date18 Feb 2019

Sponsor / Collaborator

Vichy Laboratories

NCT05096312 / CompletedPhase 4IIT

A Randomized, Double Blind, Placebo-Controlled Clinical Trial of the Effects of Oral Zinc Gluconate Among Diagnosed Acne Vulgaris Patients

Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has been described.
A randomized, double blind, placebo-controlled clinical trial was utilized for this study with the objective to assess the efficacy of oral zinc gluconate in the improvement of disease activity in acne vulgaris patients as measured by the inflammatory score and Global Acne Grading System (GAGS) score.

Start Date21 Dec 2018

Sponsor / Collaborator-

NCT03563365 / TerminatedPhase 4

A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream With Resveratrol , Replenix Power of Three Cream With Resveratrol With Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, Utilized to Treat Subjects With Facial Acne Vulgaris

A Randomized, Investigator Blinded, Single Site, Three Arm Clinical Study to Assess the Functional and Emotional Benefits of Replenix Power of Three Cream with Resveratrol , Replenix Power of Three Cream with Resveratrol with Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, and Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, utilized to treat subjects with Facial Acne Vulgaris

Start Date04 Jun 2018

Sponsor / Collaborator

Yardley Dermatology Associates P.C.

[+1]

100 Clinical Results associated with Adapalene/Benzoyl Peroxide

100 Translational Medicine associated with Adapalene/Benzoyl Peroxide

100 Patents (Medical) associated with Adapalene/Benzoyl Peroxide

Literatures (Medical) associated with Adapalene/Benzoyl Peroxide

01 May 2023·Heliyon

Immunomodulatory effect from ethanol extract and ethyl acetate fraction of Curcuma heyneana Valeton and Zijp: Transient receptor vanilloid protein approach

Article

Author: Christianty, Fransiska Maria ; Zuhra, Swara Adla ; Matsunami, Katsuyoshi ; Ghiffary, Mohammad Labib ; Pratoko, Dwi Koko ; Sulistyowaty, Melanny Ika ; Panggalih, Wulan Rosa ; Fajrin, Fifteen Aprila ; Indrianingsih, Anastasia Wheni

This study aims to discover the immunomodulatory potential of the ethanol extract (EE) and the ethyl acetate fraction (EAF) of Curcuma heyneana Valeton and Zijp (Indonesian name: temu giring) rhizome using mice models. The affinity of the curcuminoid (curcumin, dimethoxy-, and bisdemethoxy-) through the Transient Receptor Potential Vanilloid 1 (TRPV1) was determined using Mollegro molecular docking in silico. The curcuminoid concentration of the EE and EAF of C. heyneana rhizome were determined using thin-layer chromatography densitometry. In vivo studies in mice models were conducted using the carbon clearance method to determine the phagocytosis index, and the number of leukocytes in the blood and spleen. Forty mice were divided into eight groups, including negative control (given 1% CMC-Na), positive control (given Stimuno Forte® suspension at a dose of 6.5 mg/kg BW), three groups given the EAF of C. heyneana rhizome extract at a dose of 125 mg/kg BW, 250 mg/kg BW, and 500 mg/kg BW, respectively, and three groups were given EE of temu giring rhizome extract with doses of 125 mg/kg BW, 250 mg/kg BW, and 500 mg/kg BW, respectively. E.E. and E.A.F. of C. heyneana (temu giring) rhizome extract contained dimethoxy curcumin (0.176 ± 0.01 and 4.53 ± 0.02 %b/b) greater than another curcuminoid, bisdemetoxy curcumin and curcumin. EE at 125 mg/kg BW and EAF dose at 500 mg/kg B W. of temu giring rhizome have immunostimulant activity with a phagocytosis index value of >1 compared to the negative control (p < 0.05). Additionally, both increase the number of lymphocytes, monocytes, and neutrophil cells in peripheral blood and spleen compared to the negative control (p < 0.05). Their activity was seen as similar to the positive control. Therefore, the EE of C. heyneana rhizome has immunostimulant activity, and the EAF of C. heyneana rhizome has immunosuppressant activity at 125 mg/kg BW and immunostimulant at a higher dose. The activity of temu giring as an immunomodulator was associataed with its affinity to TRPV1.

01 Jun 2021·Journal of the European Academy of Dermatology and VenereologyQ2 · MEDICINE

Subclinical effects of adapalene‐benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery

Q2 · MEDICINE

Article

Author: Philipsen, P.A. ; Ortner, V.K. ; Fuchs, C.S.K. ; Hansen, F.S. ; Haedersdal, M.

AbstractBackgroundAdapalene–benzoyl peroxide (A‐BPO) is a first‐line topical treatment for acne vulgaris. In vivo reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) detect micromorphological changes over time and visualize transfollicular delivery.ObjectivesTo visualize temporal, subclinical effects of A‐BPO on acne micromorphology using RCM and OCT, and evaluate their impact on transfollicular delivery of microparticulate carrier systems.MethodsFifteen patients with mild to moderate acne received a 6‐week course of A‐BPO. Micromorphological changes were evaluated at time 0, 3 and 6 weeks with RCM (n = 1190 images) and OCT (n = 210 scans). Transfollicular delivery of microparticles was assessed at baseline and week 6.ResultsIn vivo imaging visualized steady normalization of skin micromorphology in response to A‐BPO over 6 weeks, including decreased hyperkeratinization of follicular borders (RCM median decrease −71.2%, P < 0.05), reduced intrafollicular keratinous content (RCM median decrease −47.7%, P < 0.05) and increased epidermal thickness (OCT median increase of 25.25%, P < 0.05). Imaging visualized microparticles in the follicular unit. Despite a visible reduction in keratin and sebum, transfollicular microparticle delivery appeared unaffected.ConclusionsReflectance confocal microscopy and OCT detect A‐BPO‐induced changes in micromorphology and visualize transfollicular microparticle delivery. Keratolysis and sebolysis did not have a measurable effect on transfollicular delivery of microparticles.

01 Jul 2018·European Journal of Dermatology

The safety and efficacy of four different fixed combination regimens of adapalene 0.1%/benzoyl peroxide 2.5% gel for the treatment of acne vulgaris: results from a randomised controlled study

Article

Author: Tan, Jerry ; Canosa, Juliana Machado ; Gratton, David ; Kerrouche, Nabil ; Bissonnette, Robert

BACKGROUNDCombined use of a retinoid and antimicrobial is recommended for acne, however, local tolerability issues may compromise patient adherence and treatment outcome.OBJECTIVESThis multicentre, single-blinded controlled study was designed to determine whether modified adapalene/benzoyl peroxide (A/BPO, Epiduo^®, Galderma, France) regimens improve local tolerability during the first four weeks of treatment without impairing efficacy at Week 12.MATERIALS & METHODSIn total, 120 subjects with mild-to-moderate acne received, during the first four weeks, A/BPO daily overnight (A/BPO-EN), A/BPO daily for three hours (A/BPO-3h), A/BPO daily overnight and a provided moisturizer lotion (A/BPO-moisturizer), or A/BPO every other night (A/BPO-EoN). Local tolerance assessments included signs and symptoms, global worst score (GWS), and total sum score (TSS). Efficacy was assessed based on lesion counts, investigator global assessment (IGA), and total lesion count reduction. Adherence, subject satisfaction, and overall safety were also assessed.RESULTSThe mean TSS was significantly reduced at Week 1 with A/BPO-EoN vs. A/BPO-EN (p<0.05), and A/BPO-EoN led to the lowest GWS and a decrease in severity of stinging/burning and erythema (p<0.05). The A/BPO-moisturizer regimen prevented dryness and scaling compared with the A/BPO-EN regimen. The median decrease in lesions from baseline was similar in all groups: up to 67% for total, 72% for inflammatory, and 70% for non-inflammatory lesion counts. Adherence, IGA, patient satisfaction, and overall safety were excellent.CONCLUSIONSModulating treatment regimens during the first four weeks improved local tolerability without impacting overall efficacy outcome after 12 weeks and may improve treatment adherence during the first weeks of therapy.

News (Medical) associated with Adapalene/Benzoyl Peroxide

14 Nov 2024

·www.adalvo.com

Adalvo announces successful DCP Submission for Ivermectin topical cream

Adalvo is pleased to announce the successful EU DCP Submission for Ivermectin 10mg/g topical cream. Our Ivermectin cream is being developed in collaboration with one of our strategic partners, based on the reference brand Soolantra, Galderma. The product is used on the skin to treat pimples and spots found with rosacea. According to IQVIA, the INN with strength 1%(10mg/g) generated approximately $214mn in global sales in 2022. With our clearly defined product pathway, we believe Adalvo will be amongst the first wave of filers, and will be ready to launch on Day-1 in all major markets. As a company committed to our dermatology portfolio, we offer an array of dossiers and aim to assist our partners in overcoming any challenges that may arise with these mature products. Our dermatology products include: Adapalene Gel Adapalene + Benzoyl Peroxide Gel Tacrolimus Ointment Dimetindene Gel

13 Oct 2023

·www.biospace.com

Galderma Unveils Bold Ambition in Neuromodulation at Liquid Live Event

At the Liquid Live event in Dubai, the Company gears up for launch of Alluzience® in next wave of countries and presents exciting pipeline update ZUG, Switzerland--(BUSINESS WIRE)-- Galderma, the emerging pure-play dermatology category leader, today hosts the first edition of its Liquid Live event in Dubai as a chance to discuss with clinicians the future of innovation in the field of neuromodulation as well as showcasing the latest neuromodulators from its aesthetics portfolio. This press release features multimedia. View the full release here: Copyrights - Sylvain Granjon To mark the progress in treatment optimization and showcase its commitment to further driving innovation, Galderma has organized the first ever Liquid Live event. This premium experience will convene over one hundred of Europe’s leading aesthetics practitioners to immerse themselves in the future of the neuromodulator field. The Liquid Live event will include presentations from renowned experts on key data, the latest market trends and changes in patient needs, and sharing insights to advance the future of neuromodulation in aesthetics together. A year on from the launch of Alluzience®, the first and only liquid ready-to-use neuromodulator in Europe with rapid onset and effects lasting for up to six months, Galderma is now getting ready to launch the product in 13 new countries1. Indicated for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines, this launch opened a new era of innovation in neuromodulation. As a ready-to-use liquid formulation, it has the potential to improve safety and dosing accuracy compared to existing neuromodulators that require reconstitution, enabling more precision and higher patient satisfaction. “Galderma is the leading innovator in neuromodulators and we are delighted to launch the Liquid Live event as an opportunity to convene leading experts in this field. Alluzience® has a unique pro its launch in 13 new countries is another exciting step in our journey of driving differentiated innovation and expanding our portfolio. Galderma has a strong track record as an innovator in neuromodulation having launched the first liquid neuromodulator, as well as the first neuromodulator with a six-month duration of action, and is committed to further innovation. Liquid Live offers the ideal platform for us to come together as we prepare to launch this unique product more broadly and explore the many possibilities for the future of neuromodulation together.” GERRY MUHLE HEAD OF GLOBAL PRODUCT STRATEGY GALDERMA Galderma is well-positioned to continue to build its category-leading pipeline in injectable aesthetics, with proven in-house R&D capabilities in medical aesthetics. This includes successfully developing RelabotulinumtoxinA internally as well as the world’s largest hyaluronic acid filler range, Restylane®. Along with Sculptra®, the first and original injectable poly-L-lactic acid collagen stimulator, Galderma’s offering in neuromodulators and fillers is the broadest, unparalleled injectable aesthetics portfolio. About Alluzience® Alluzience (abobotulinumtoxinA solution) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment. Dosing and treatment intervals depend on assessment of the individual patient’s response. The treatment interval should be no more frequent than every three months. For more information, please see the Summary of Product Characteristics2. Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in Europe. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane®, Dysport®, Azzalure®, Alluzience® and Sculptra® in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin Skincare® in Dermatological Skincare. For more information: ---------------- 1 Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Romania, Slovenia and Slovakia 2 Alluzience Summary of Product Characteristics, 2023 View source version on businesswire.com: Contacts For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Source: Galderma Smart Multimedia Gallery Photo Copyrights - Sylvain Granjon Photo Copyrights - Sylvain Granjon Photo Copyrights - Sylvain Granjon Logo View this news release and multimedia online at:

License out/in

02 Oct 2023

·www.biospace.com

Galderma announces progress with RelabotulinumtoxinA regulatory submissions

Galderma receives FDA Complete Response Letter with comments isolated to Chemistry, Manufacturing, and Controls items International Chamber of Commerce (ICC) arbitration is complete and the regulatory applications are under review Regulatory filings in other territories are ongoing and remain on track ZUG, Switzerland--(BUSINESS WIRE)-- Galderma, the emerging pure-play dermatology category leader, announced today updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA (QM-1114) to the U.S. Food and Drug Administration (“FDA”). The FDA has issued a Complete Response Letter (“CRL”) to Galderma related to its BLA for RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines (frown lines) associated with corrugator and/or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis oculi muscle activity in adult patients. The CRL points out certain deficiencies isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed. Galderma has already identified changes to the manufacturing process to address feedback. It will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant issues. Further update on the regulatory filing strategy of RelabotulinumtoxinA and broader neuromodulator R&D partnership On September 28, 2023, the International Chamber of Commerce (ICC) issued its award on the arbitration commenced by Galderma in 2021 regarding the regulatory filing strategy for RelabotulinumtoxinA, and as a result, the arbitration is complete. While the award is confidential, the result is that the applications submitted for regulatory review are proceeding according to the initial strategy and Galderma and Ipsen await further feedback from regulators. Galderma remains responsible for development, regulatory filing and strategy, manufacturing, and commercialization. Interactions with regulatory authorities remain the responsibility of Galderma. Regulatory approval submissions and issued certificates will ultimately be in the name of Ipsen. The ICC award has no impact on the ongoing European decentralized procedure for the filing of RelabotulinumtoxinA nor on the commercialization of Galderma’s neuromodulator portfolio. Regulatory submissions in other territories are ongoing and remain on track. Furthermore, in a press release dated July 27, 2023, Ipsen made statements about the purported termination of the Galderma-Ipsen Research and Development (R&D) partnership. Galderma contests those statements and remains committed to resolution with Ipsen. Galderma remains committed to bringing scientific innovation to its healthcare professionals, consumers and patients globally by expanding its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane®, Dysport®, Azzalure®, Alluzience® and Sculptra® in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin Skincare® in Dermatological Skincare. For more information:

100 Deals associated with Adapalene/Benzoyl Peroxide

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	US	Galderma Laboratories LP	08 Dec 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00422240 (CTgov)	Phase 3	Acne Vulgaris	1,668	Adapalene/Benzoyl Peroxide (Adapalene/Benzoyl Peroxide Gel)	wmqqfcxfea(rpxmezkeit) = mxysbzzumj bbziefdfem (ouowiwpxun, ijkvysqnun - nzzmmtsssq) View more	-	15 Apr 2024
				Adapalene Gel, 0.1% (Adapalene Gel, 0.1%)	wmqqfcxfea(rpxmezkeit) = nguamaphst bbziefdfem (ouowiwpxun, tkmncrqmhe - hsrcgmayqo) View more
NCT00446043 (CTgov)	Phase 3	Acne Vulgaris	452	Adapalene/Benzoyl Peroxide	(oxtqojrxce) = udwkjyykjr riueoczhox (flyrnbgbho, zxjcpqkldu - gtxinmzqbn) View more	-	11 Jul 2023
NCT02899000 (CTgov)	Phase 4	Acne Vulgaris	186	Oral doxycycline hyclate+Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel	kmycymlfuh(auhfncgbgv) = zttmxgrofk qnwhqnvbyr (qpgfejeawi, rlnevgqhqh - nlkxezrgeq) View more	-	09 Dec 2022
NCT05096312 (CTgov)	Phase 4	Acne Vulgaris	23	Zinc gluconate+Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] (Zinc Gluconate Group)	ulcdkqrfgc(ryxfrhvpkj) = xopwozshef sineindykq (kdsacerkvg, qnzkhkzgqd - caosobrvzs) View more	-	13 Apr 2022
				Placebo+Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo] (Placebo Group)	ulcdkqrfgc(ryxfrhvpkj) = ncvlpqghps sineindykq (kdsacerkvg, dwzomcltgb - iaavllsudp) View more
NCT02735421 (OSCAR, CTgov)	Phase 4	Atrophic acne scar \| Acne Vulgaris	67	ABPO Forte Gel (Part 1: ABPO Forte Gel)	ibnvrjlsaf(cvurpuezfr) = aranbbzqfl kwgfjumfeg (nvrzrjxmuk, xkvysojfyg - bgrdmdwzgn) View more	-	15 Nov 2019
				Vehicle gel (Part 1: ABPO Forte Vehicle Gel)	ibnvrjlsaf(cvurpuezfr) = mdmlnrpica kwgfjumfeg (nvrzrjxmuk, czyvmniqzb - pkeddncepm) View more
NCT02932267 (EDeN, CTgov)	Phase 3	Acne Vulgaris	50	Adapalene 0.3% / BPO 2.5% gel	fiuldegbyp(wmzzqxyvwb) = fsmvqczmmp dxgsuzptlf (vcujrucvxd, zvzzudcogo - njkaaoggsa) View more	-	15 Nov 2019
NCT01504204 (CTgov)	Phase 4	Acne Vulgaris	20	Adapalene + benzoyl peroxide samples (Medication With Sample and Demonstration)	kbwxbkuatp(gclhcthnxq) = leukcgkrve ubdmabgwcy (vuajbtkfsg, yamfpcnzgv - cyrnmoynqp) View more	-	23 Jan 2018
				Adapalene + benzoyl peroxide from standard tube (Medication Without Samples)	kbwxbkuatp(gclhcthnxq) = phrcnlmiug ubdmabgwcy (vuajbtkfsg, gsbsyclvgh - mjefchkxvf) View more
NCT01474590 (POWER, CTgov)	Phase 3	Acne Vulgaris	266	doxycycline 200mg+Epiduo/Tactuo (Epiduo/Tactuo + Doxycycline 200mg)	ceegdmrrzr(gglafkinkw) = zgjoeczqum xgqnychlhr (ynxdstmhnd, xdgkfnfsfz - cgsnagnalv) View more	-	28 Aug 2017
				vehicle gel+Isotretinoin (Isotretinoin + Vehicle Gel)	ceegdmrrzr(gglafkinkw) = diiglwreve xgqnychlhr (ynxdstmhnd, qpdlisxgmx - wtlvgvkqce) View more
NCT01910064 (CTgov)	Phase 3	Acne Vulgaris	436	GK530G	vzckdxuviw(clfsvnskau) = emxpzlvjgk vehlivoweu (ekbdyfppum, bdrakquzxp - prddgaqair) View more	-	05 Jan 2017
NCT02073448 (CTgov)	Phase 3	Acne Vulgaris	417	CD0271 (CD0271)	kupblfxsdj(gccwecuutn) = wxjemnzabb wynllcinpf (nfccttezpw, fbgjhnzhkt - hpyhgonajc) View more	-	03 Nov 2016
				GK530G (GK530G)	kupblfxsdj(gccwecuutn) = ioxkkszcpm wynllcinpf (nfccttezpw, kjanyvfuyy - swxzbncfsx) View more

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