Royal and Pontifical

The Catholic University of the Philippines

UNIVERSITY OF SANTO TOMAS
Faculty of Pharmacy
España, Manila

PHA6123 Laboratory Activity 4

Non-inferiority Trials
Instructions:
1. Each group would have an assigned journal to read and work on. These journals will show the
students on how a non-inferiority trial works, its difference from a regular randomized control
trial and how can one treatment become non-inferior from the usual/innovator treatment.
2. Submit your output on the first hour of the next laboratory period (7 am – 3B Pharmacy, 1 pm
– 3H Pharmacy)
3. Format: US Letter, size 12 normal margin, saved as pdf file; File Name and Heading of Email:
Group Number, Section, Activity (eg. Group4_3BPharmacy_Activity4.pdf)
4. Submit to my email address: hpmanalili@ust.edu.ph
5. Read the assigned journal, and answer the following questions: (some journals are in their
open access format: simply click the link, click download this article, and save directly on your
desktop; some are google drive links which can be downloaded immediately). Please cite the
location of your answer from the journal for checking (eg. P.3, Methodology); just indicate the
heading of your answer if there is no page number in your assigned journal (eg. Methodology).
Please cite all the additional reference/s that you have used to answer the more detailed
questions.
a. What is the objective of the study?
b. What are the group/s that are being compared in your study?
c. What is the type of study used? Was there randomization done?
d. What are the parameters being measured in your study (including endpoints if
mentioned)?
e. In what way can you say that the test drug/s/procedure is/are non-inferior to the
usual/innovator treatment?
f. As the only pharmacist in the dermatology clinic, your dermatology consultant ask you to
answer the questions based on the journal provided (Look at your Group Number).
• Group 1: A 20 year-old Filipino female came in the clinic presenting with 20 tense
blisters all over the body. Diagnosis is bullous pemhigoid. The dermatologist is
wary of using high-dose prednisolone because of its side effects. Will you
recommend doxycycline? Why or why not?
• Group 2: A 70 year-old Filipino female who was a former market vendor came in
the clinic presenting with a 0.2 cm friable ulcer on the trunk. Diagnosis was low
risk superficial basal cell carcinoma. Given her age, would you recommend
surgical excision or just topical imiquimod? Justify your answer.
• Group 3: A 9 year old female from Papua New Guinea travelled back here in the
Philippines. Her mother sought consult to the dermatology clinic because she
noticed that her child had some multiple erythematous rubbery plaques on the
upper and lower extremities. Clinical diagnosis was to consider yaws. If this were
yaws, would you recommend an oral regimen (Azithromycin) or intramuscular
one (Benzathine Penicillin G)?
• Group 4: A 70 year-old Filipino diabetic female who was a former golfer came in
the clinic presenting with a 0.5 cm friable ulcer on the face. Diagnosis was
superficial basal cell carcinoma. Given her age, would you recommend
photodynamic therapy or just topical imiquimod/fluouracil? Justify your answer.
 • Group 5: A 40 year old Filipino businesswoman had a 1 year history of recurrent
generalized edematous plaques and wheals. Patient was diagnosed by the
consultant with chronic spontaneous urticaria. Patient had elevated ASST and
APST upon consult. Your consultant is contemplating on using Azathioprine to
control the patient’s symptoms. Would you recommend giving Azathioprine?
Why or Why not?
• Group 6: A 40 year old male had a one year history of multiple erythematous
plaques on the trunk and extremities. Diagnosis was chronic plaque psoriasis.
Patient had a few episodes of recurrences because he is on a maintenance dose
of phototherapy (three times a week) but was not able to go to the clinic because
of the lockdown. Would you recommend a home ultraviolet B photherapy
instead? Why or why not?
• Group 7: A 5 year old male came in to the clinic for follow up. Patient is a clinically
diagnosed case of atopic dermatitis presenting as multiple erythematous plaques
on the antecubital and popliteal fossa already controlled with clobetasol ointment
and oral erythromycin for 1 week. Your consultant would want to start the patient
on a pro-active management to lessen the use of a class I steroid such as
clobetasol ointment since the lesions are already controlled. Would you
recommend using tacrolimus 0.03% ointment of fluticasone 0.005% ointment?
Justify your answer.
• Group 8: A 40 year old Brazilian who is in the Philippines for a vacation came in to
the clinic because of multiple erythematous to violaceous plaques with ulcer on
the trunk. Biopsy was done as well as HIV serology which revealed advanced
Kaposi sarcoma and a positive western blot confirming HIV, respectively.
Laboratory results showed the following results: absolute neutrophil count of
1000 cells per uL, hemoglobin of 9mg/dL, creatine clearance of 60 mL/minute,
normal liver function tests and bilirubin. Patient was referred to Oncology for co-
management. Among the choices in the journal (etoposide, paclitaxel, bleomycin,
vincristine), which one can you recommend together with anti-retroviral
treatment (ART)? Justify your answer.
Group No. Title of Journal Link
1 Doxycycline versus prednisolone as an https://reader.elsevier.com/r
initial treatment strategy for bullous eader/sd/pii/S014067361730
pemphigoid: a pragmatic, non-inferiority, 5603?token=7B91FA84CB8B6
randomized control trial 5D72230B5F34466F45705842
8D5E6505918FE4D9F3929A90
4870CEFF66B850609E594010
03E730C1858
2 Surgical excision versus imiquimod 5% https://reader.elsevier.com/r
cream for nodular and superficial basal-cell eader/sd/pii/S147020451370
carcinoma (SINS): a multicentre, non- 5308?token=AA4FE3C99B5C8
inferiority, randomized control trial D5F811AD0DBEDDF04496576
FBD521BF0D35D20138191BD
763988EE113E0029687FBA18
4E7E6DA473778
3 Single-dose azithromycin versus benzathine https://drive.google.com/file/
benzylpenicillin for treatment of yaws in d/1tppJtUWL_bf4uFd96fa1pq
children in Papua New Guinea: an open- 4oUSL80pya/view?usp=sharin
label, non-inferiority, randomized trial g
4 Photodynamic therapy versus topical
imiquimod versus topical fluorouracil for
treatment of superficial basal-cell
carcinoma: a single blind, non-inferiority,
randomized controlled trial
5 Comparing azathioprine with cyclosporine
in the treatment of antihistamine refractory
chronic spontaneous urticaria: A
randomized prospective active-controlled
non-inferiority study
6 Home versus outpatient ultraviolet B
phototherapy for mild to severe psoriasis:
pragmatic multicentre randomized
controlled non-inferiority trial (PLUTO
study)
7 Efficacy of tacrolimus 0.03% ointment as
second-line treatment for children with
moderate-to-severe atopic dermatitis:
evidence from a randomized, double-blind
non-inferiority trial vs. fluticasone 0.005%
ointment
8 Treatment of advanced AIDS-associated
Kaposi sarcoma in resource-limited settings:
a three-arm, open-label, randomized, non-
inferiority trial
Thank you! Study hard! ☺
https://drive.google.com/file/
d/1uOl5wbV6CsKlkbNNU8AjC-
lHAG0FgFgI/view?usp=sharing
https://reader.elsevier.com/r
eader/sd/pii/S193945511930
3667?token=A1E5CDF0375A7
47D381E369706247B3870F61
30248A4BB3E9DB62341F1905
541B15784A37DFD411567927
918B4400F5A
https://www.bmj.com/conte
nt/bmj/338/bmj.b1542.full.p
df
https://drive.google.com/file/
d/15J_GNd0XPDxZm8rJPqmbZ
kOX8TaDFT2q/view?usp=shari
ng
https://reader.elsevier.com/r
eader/sd/pii/S014067361933
2222?token=B33906D9F1025
36D85081ED66E0E9776FA59A
DD03E3DA025D4FA549A201A
275F47744AD919BD450208D
0D150847EF718