... controlled study of appro priate size; d III Evidence from well designed trials without randomization, single group pre/post, cohort, time series, or matched case controlled studies; d IV Evidence from well designed nonexperimen ...

In addition, very few studies have compared light based treat ments with standard and well validated pharma ceutical treatments and none with the current recommended therapy for most types of acne combination therapy with a topical ...

Nonetheless, it seems that the use of lasers and light therapy alone or with photosensi tizers offer promise.

... SEARCH RE PORT Information on patent family members International application No PCT/US20 1 0/04367 1 Publication Patent family date member(s) Patent document cited in search report Publication date I I I us 20071 22435 NONE ...

Summer AAD, Boston, MA July 2009 “Promiseb™ Topical Cream for the Treamtent of Mild to Moderate Seborrheic Dermatitis of the Face – A Pilot Study” Michale Jarratt M.D., James DelRosso M.D., Zoe Draelos M.D, Steven Kempers M.D., Leon Kircik M.D., Lawrence Parish M.D., Alan Mentor M.D., Boni Elewski M.D.

EADV, Istanbul Turkey, May 2008 “Moisturizer Use Enhances Facial Tolerability of Tazarotene 0.1% Cream Without Compromising Efficacy in Patients with Acne Vulgaris” Emil Tanghetti M.D., Zoe Draelos M.D., Pearl Grimes M.D., Sunil Dhawan M.D., Michael Gold M.D., Leon Kircik M.D., Lawrence Green M.D., Angela Moore M.D., Fran Cook-Bolden M.D.

32nd Annual Hawaii Dermatology Seminar, Waikoloa, HI, March 2008 Promiseb™ Topical Cream for the Treamtent of Mild to Moderate Seborrheic Dermatitis of the Face – A Pilot Study” Michale Jarratt M.D., James DelRosso M.D., Zoe Draelos M.D, Steven Kempers M.D., Leon Kircik M.D., Lawrence Parish M.D., Alan Mentor M.D., Boni Elewski M.D.

International Academy of Cosmetic Dermatology, Melbourne, Australia, December 2006 “Utilization of Narrow-Band UVB Light Therapy and Etanercept for the Treatment of Psoriasis (UNITE): Efficacy, Safety, and Patient-Reported Outcomes” Leon Kircik, Jerry Bagel, Neil Korman, Alan Menter, Craig A. Elmets, John Koo, Yu-Ching Yang, Chiun-Fang Chiou, Frank Dann, Seth R. Stevens EADV Rhodes, Greece, October 2006 “A Double-Blind, Randomized, Vehicle-Controlled Trial to Determine the Efficacy and Safety of Hydrocortisone Butyrate 0.1% Lipocream in the treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects William Abramovits, M.D., Elizabeth Alvarez-Connelly, M.D., Debra Breneman, M.D., Alicia Bucko, M.D., Zoe Draelos, M.D., Lawrence Eichenfield, M.D., Michael Jarratt, M.D., Candice Johnson, M.D., Steven Kempers, M.D., Leon Kircik, M.D., Robert Loss, M.D, Robert Matheson, M.D., Elaine Siegfried, M.D., Dow Stough, M.D., Hector Wiltz, M.D.

Sun City, South Africa Sept. 2014 “New Treatment in Psoriasis” DEF NPPA Meeting Las Vegas, NV July 2014 “Treatment of Erythema in Rosacea” Spring EADV Belgrade, Serbia May 2014 “Topical Ivermectin” Innovations in Acne and Rosacea Monte Carlo, Monaco May 2014 “Importance of Vehicles” Derm Update Toronto, Canada April 2014 “What’s New in Medicine Cabinet”

8 The intensity of fluorescence was graded on a O to 6 scale with O = none, 1 to 2 = mild fluorescence, 3 to 4 == moderate, and 5 to 6 = heavy fluorescence.

Safety of Drug Product The main issue of discussion with the applicant for labeling was whether patients to be treated with ACZONE Gel, 5%, should have glucose 6-phosphate dehydrogenase (G6PD) and complete blood count evaluations.

In fact, the data provided by the sponsor regarding ACZONE Gel treated patients in their study DAP0I 10 suggest a drop in hematocrit (see graph below).

It will be important to have any further studies conducted to carefully address this by evaluating dapsone levels along with documenting changes in hematocrit, reticulocyte count, and other hematologic parameters.

The applicant did not enroll adequate numbers of subjects with glucose 6-phosphate dehydrogenase (G6PD) deficiency in the clinical studies to be able to make reasonable conclusions about the safety of ACZONE Gel in this population.

3) The applicant stated they had produced at their own risk approximately -... professional sample tubes with labeling prior to Agency evaluation and approval (see graphic below).

- All articles and notices for publication, general correspondence, and inquiries should be addressed to the Editor, Department of Microbiology, Faculty of Medicine, Siriraj Hospital (Phone 4110241ext.

- For the type of material acceptable for this journal, and information regarding the processing of manuscripts, proofs, read "A Guide for Contributors' which is published in the January issue cf the J. Med.

This material may be protected by Copyright law (Title 17 U.S. Code) Incidence of Anemia in Leprosy Patients Treated with Dapsone* Siripen Puavilai, M.D., ** Saengsuri Chutha, M.D., ** Niwat Polnikom, M.D., ** Penwadee Timpatanapong, M.D., ** Pariya Tasanapradit, M.D., ** Somyot Charuwichitratana, M.D., ** Achara Boonthanom, M.D.

These included complete blooo count (CBC), urinalysis, stool examination, reticulocyte count, methemoglobin, Heinz body, Conmbs' test, blood urea nitrogen (BUN), creatinine, lactic dehydrogenase (LDH), serum g!utamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transa minase (SGOT), total protein, albumin, bilirubin and urine hemosiderin pigment.

These findings contrasted with the previous that studies done by De Gowin who demonstrated normal G-6-PD patients could take 100 mg dapsone per day without easily detectable hemolysis<6l.

Nonetheless, these variations are within the scope of the invention, as the lightly- to moderately-crossl inked PVPs thicken low pH compositions.

Almirall, LLC Exhibit 2002 Page 38 DN 3168 P3 Table 5: Discomfort/sting intensity scale used in Example 10 numerical scale rating volunteer perception 0 0.5 1.0 1.5 2.0 2.5 3.0 none barely perceptible slightly perceptible definitely ...

In recent years, there has been great interest in the use of novel polymers with complex functions as emulsifiers and thickeners because the gelling capacity of these compounds allows the formulation of stable emulsions and creams by decreasing surface and interfacial tension and at the same time increasing the viscosity of the aqueous phase.

Application of this model and calculation of the relative spectra revealed the increasing elasticity of this system compared to the 0.5% concentration, as confirmed by the higher values of the plateau modulus (491.6 Pa), shear viscosity (870.6 Pa s), and characteristic relaxation time (170.6 s.).

The time sweep performed to check sample recovery after shear showed that emulsions were unable to recover their structure during the test, as confirmed by the smaller moduli values (data not shown).

It is important to note that the dynamic moduli obtained from acoustic spectroscopy meas- urements are not comparable with those derived from rotational rheometers working in the oscillation mode, since the applied stress is not tangential, as in an oscillatory experiment, but “normal,” and the tested frequencies are much higher.

Instead, a different behavior was present in the low frequency region, where the curve related to the system analyzed after 1 day revealed a trend very similar to that of the corresponding Sepineo sample (3% w/w concentration), which showed, as previously mentioned, a certain deform- ability.

Nonetheless, no reliable way exists to predict the risk for dapsone hypersensitivity.