A research information guidelines to discuss the matter to the selected participants disclosing all necessary information before conducting an assent/informed consent.

1. RESEARCH INFORMATION SHEET
Introduction
I am __________________________________ and currently on __________________ at
______________________________(institution) in _____________________________________
(address). We are doing research on Pityriasis Versicolor, a type of skin disease, which is very common in
this country and to compare two types of drugs for treatment; Ketoconazole and Virgin Coconut Oil. I am
going to give you information and invite you to be part of this research. Before you decide, you can talk to
anyone you feelcomfortable with about the research,that can explain further about your query. There may
be some words that you do not understand. Please ask me to stop as we go through the information and I
will take time to explain. If you have questions later, you can ask them of me, the associate doctor or my
other research staff.
Purpose of the Research
Pityriasis Versicolor is one of the most common skin disease in the Philippines caused by yeast
that is normally lives in skin of every person, but if it grows progressively in different parts of the body due
to hot and humid temperature specifically to individual with oily skin and has weak immune system then it
leads to skin problem.
The drugs that is considerably prescribed to treat this type of skin disease is ketoconazole, a cream
form which apply topically directly to affected area. Ketoconazole drug is available in any drug store
however, it is expensive that mostly cannot afford to buy it and opt not to comply for treatment. On the
other hand, Virgin Coconut Oil has been known to respond positively to individuals using it as supplement
and is much cheaper and accessible mostly at the mall or store. According to Elmore (2014) coconut oil has
been used as an antibacterial, antifungal, and antiviral agent for skin diseases. The reason we are doing this
research is to determine the efficiency of virgin coconut oil in the outcome of treatment and compare with
the effect of ketoconazole treatment.
Type of Research Intervention
This research will involve a thorough clinical assessment including health history prior to
the clinical application of topical cream to affected skin either ketoconazole or Virgin Coconut Oil
(VCO) as to pre-qualify in the selection for study and treatment of Pityriasis Versicolor.
The selected drugs be applied twice daily, once in the morning and once in the afternoon for two
weeks. After every week of treatment,assessment will be conducted by the research associate taking photo
of the affected skin area, make documentation and also get skin sample for KOH test by the Licensed
Medical Technologist. Taking a skin sample is painless and non- invasive procedure. The KOH test is one
type of skin test that would determine if the person is either negative or still positive of Pityriasis Versicolor
and will be conducting KOH test three times during the entire research period to every participants.
The research associates will visit and examine the participants three times for the entire period of
study, excluding during the signing of the informed consent with the Parent/Guardian, orientation phase
and discussion of the researchfindings, unless there is highly need to interact with the participant in regards
to the outcome of treatment for further evaluation and intervention.
Participant Selection

2. We are inviting the Parents/Guardian with children age 18 and below diagnosed with Pityriasis
Versicolor who attended in any Dermatological Clinics to participate in the research on the efficiency of
treatmentof both Virgin Coconut Oil and Ketoconazole. We will also conduct physical assessmenttoscreen
children in the chosen Brgy. Health Center and Elementary School for any positive of Pityriasis Versicolor
and then ask consent for research participation.
Voluntary Participation
In order for minors (younger than 18 years of age) to participate in a research study, parental or
guardian permission must be obtained. For minors younger than 7 years of age, only a parental permission
form is required. For minors age 7-12, a child assent form be provided, and for minors age 13-17,
categorized as the youth assent and be given assent form format to be signed. A copy of signed assent form
will be provided to the parent/guardian.
Your participation in this research is entirely voluntary. It is your choice whether to participate or
not.
When the participants choose to participate in this research,the services receive at the clinic where
the participant attended will continue except for the specific drug provided by the research team for
treatment of Pityriasis Versicolor. (Further explanation discuss in the next page).
To those children (below 18 years old) in Brgy. Health Center and/or Elementary School examined
and just currently been diagnosed with Pityriasis Versicolor and you choose to participate in this research,
will receive treatment provided by the research team within two weeks period. (Further explanation discuss
in the drug trial on the next page.)
On the other hand, if the Participant/Parents/Guardian in Brgy. Health Center and/or Elementary
School examined and diagnosed with Pityriasis Versicolor chooses not to participate in this research, they
will be referredto Skin Specialist and be routinely attendedfor standard treatmentat your expense. (Further
explanation discuss in the next page.)
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so. You may also stop
participating in the research at any time you choose. It is your choice and all of your rights will still be
respected, and you will be referred to a Derm Specialist and be provided with the established standard
treatment available at the centre/institute/hospital.
Information on the Trial Drug namely Ketoconazole and Virgin Coconut Oil
There are two types of drug we are testing in this research,the Ketoconazole and Virgin Coconut
Oil.
Ketoconazole is used to treat fungal infections of the skin and is available at any drug store as a
cream form in 2% strength. This medicine works by killing the fungus or yeast, or preventing its growth.
You should know that there is side effects. The visible side effects are: change in hair texture, blisters on
scalp and dry skin. The doctor advise to stop ketoconazole treatment if there is manifestations of serious
side effects such as; severe itching, rash, hives, difficulty breathing or swallowing, redness,warmth in the
place where you applied the medication (WEBMD, 2016).
The Virgin Coconut Oil is a coconut oil that is high in healthy saturated fats. These fats can boost
fat burning and provide your body and brain with quick energy. They also raise the good HDL cholesterol
in your blood, which is linked to reduced heart disease risk. Also, coconut oil is naturally antibacterial and

3. antifungal, and for the skin, is an excellent moisturizer. Coconut oil predominantly contains a fatty acid
called lauric acid, which has anti-inflammatory properties. The word ‘virgin’ means raw unrefined coconut
oil which is the best coconut oil for skin care because it contains all the naturally occurring phytonutrients
and polyphenols.
Coconut oil is likely safe when applied to the skin and when taken by mouth in food amounts. But
coconut oil contains a type of fat that can increase cholesterol levels. So people should avoid eating coconut
oil in excess. Other known side effects if taken or use topically on skin are: acne breakout for individual
with excessively oily skin and allergic reactions in children.
The Virgin Coconut Oil in cream to be used for this research is available at ___________ (store)
in _________________________________ (address) in product called Coco Body. This VCO product in
cream form owned by ___________________, contact information: Cellphone No. _______________,
manufactured at _________________________________ (address).
Procedures and Protocol
The following procedures will be followed in a step-by-step basis.
1. Protocol for a group selection
1.1 Because we wanted to determine the outcome of treatment for Pityriasis Versicolor and compare its
efficiency between VCO and ketoconazole. To do this, we will put children taking part in this research
into two groups. The groups are selected by chance, as if by tossing a coin.
It is important that neither you (Participant/Parent/Guardian) nor we (ResearchersandAssociates) know
which of the two drugs you are given to avoid bias in the application process, except for the licensed
Pharmacist who will do the repackaging, encoding and distribution of these two drugs.
This information will be in our files, but we will not look at these files until afterthe researchis finished.
This is the best way we have for testing without being influenced by what we think or hope might
happen. We will then compare which of the two has the best results.
1.2 Participants in one group will be given the test drug while participants in the other group will be
given the drug that is standard treatment for Pityriasis Versicolor.
2. Application of Treatment and Follow-ups
2.1 The healthcare workers who initially examined/evaluated the participants will be looking after them
and other participants very carefully during the entire period of study. They will do thorough assessment
of the outcome of treatment during the first and second week period to determine the recovery. The
assessment may took place either at the hospital/clinic, Brgy. Health Center or in the School Clinic.
2.2 The healthcare workers will take a photo of the affected skin, get skin samples and send for KOH
test conducted by the licensed Medical Technologist.
2.3 The Parents/Guardian will be provided with the selected drugs for treatment of the participants
(children). The Parents/Guardian will be given direction on the proper application of the cream twice
daily by the healthcare provider.
2.4 The School Nurse also participates in the research.He/She will do the application of treatmentduring
school days period of the participants to ensure the continuity and preventing from missed treatment.

4. 2.5 The healthcare providers/research associate will do regular calls/send text messages for reminders
of the due time of treatment at home to avoid any missed application of the cream.
3. Response of Treatment & Potential Risk
All participants in this research study will receive a 2-week treatment period provided that there are certain
circumstances that need to be considered such as:
3.1 If we find that the medicine that is being applied does not show desired effect,or not to the extent
that we wish it to have specifically associated but mild signs and symptoms of adverse reaction but not
necessarily uncomfortable for the participants; the treatment will be continued for targeted treatment
period, afterwards the participants will be re-examined and treatment will be disclosed and be provided
with standard treatment with free of charge.
3.2 If we find that the medicine that is being used does not showdesired effect but instead worsen and
associated with signs and symptoms of adverse reaction and the participant is uncomfortable with it;
the treatment will be discontinued. The participants will be re-examined and treatment will be disclosed
then referred to Dermatologist and be provided with standard treatment and expense at our cost during
the initial consultation and treatment.
3.3 If we find that the medicine that is being used show desired effect orfully treated after the first week
period of treatment based on the result of KOH test from a skin sample, the treatment still be continued
and drugs applied should not be disclosed until the end of the targeted treatment period.
3.4 If by chance you happened to misplace the drugs and cannot be found, kindly contact us immediately
for replacement as not to miss the treatment.
Benefits
If you participate in this research,you will have the following benefits: any interim illnesses will
be treated at no charge to you. If the child participant falls sick during this period he/she will be treated free
of charge. There may not be any benefit for you but your participation is likely to help us find the answer
to the research question. There may not be any benefit to the society at this stage of the research,but future
generations are likely to benefit.
Confidentiality
With this research, something out of the ordinary is being done in your community/school. It is
possible that if others in the community are aware that you are participating, they may ask you questions.
We will not be sharing the identity of those participating in the research.
The information that we collect from this research project will be kept confidential. Information
about you and your child that will be collected during the research will be put away and no-one but the
researchers willbe able to see it. Any information about you will have a number on it instead of your name.
Only the researchers will know what your number is and we will lock that information up with a
lock and key. It will not be shared with or given to anyone except the Researcher (Name stated on the first
page) who will have access to the information, including research associates, DMSFH board, Research
Committee and your Clinician.
Sharing the Results

5. The knowledge that we get from doing this research will be shared with you through a meeting
before it is made widely available to the public. Confidential information will not be shared. There will be
small meetings in the community and these will be announced. After these meetings, we will publish the
results in order that other interested people may learn from our research.
Who to Contact
If you have any questions you may ask them now or later, even after the study has started. If you wish to
ask questions later, you may contact any of the following:
NAME:_______________________________________________________________________
ADRESS: _____________________________________________________________________
TELEPHONE/CELLPHONE NUMBER:_____________________________________________
EMAIL ADDRESS:______________________________________________________________
NAME:_______________________________________________________________________
ADRESS: _____________________________________________________________________
TELEPHONE/CELLPHONE NUMBER:_____________________________________________
EMAIL ADDRESS:______________________________________________________________
NAME:_______________________________________________________________________
ADRESS: _____________________________________________________________________
TELEPHONE/CELLPHONE NUMBER:_____________________________________________
EMAIL ADDRESS:______________________________________________________________
This proposalhas beenreviewedandapprovedby ResearchCommittee andEthic ReviewCommittee
in _____________________________whichis a committee whose taskitis to make sure thatresearch
participants are protected from harm which is supporting this study. Ifyou wish to find more about
the committee, please contact [name, address, telephone number.])
__________________________________________________________________ .