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Comparison of remission index of nanofiber loading acyclovir- melisa and nanofiber loading acyclovir and mucoadhesive cream formula on Recurrent-Herpes-Labialis

Protocol summary

Study aim
Comparison of therapeutic effects of acyclovir- melissa nanofiber patch and cream with acyclovir nanofiber patch and cream on recurrent herpes labialis
Design
Four arm parallel groups randomized clinical trial, double-blinded, phase 2 on 80 patients, randomization was employed by permuted block randomization method with a block size of 4
Settings and conduct
This study was performed in the Department of Oral Diseases, Isfahan University of Medical Sciences. The lesions were diagnosed by a specialist and informed consent was obtained from the patients. The 4 study groups used 15 nanofiber patches of acyclovir-melissa, acyclovir-melissa cream,15 nanofiber patches of acyclovir and an acyclovir cream respectiveyl,three times a day for 5 days. Patients recorded symptoms on ​​a daily basis and were asked to prepare images from the lesion daily. As soon as evidence of healing and crusting was observed in the images, the patient was referred for clinical examinations. Patients and clinician were unaware of the contents of the packages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: secondary lesions and in the vesicular stage (size <1 cm) Exclusion criteria: allergy to acyclovir and other drugs, systemic and inherited or acquired immunodeficiency disease, pregnancy, lactation, use of contraceptives, antiviral and anti-inflammatory drugs, steroids and analgesics
Intervention groups
Four intervention groups of acyclovir-melissa nanofiber patch, acyclovir- nanofiber patch, acyclovir-melissa acyclovir-melissa and acyclovir cream
Main outcome variables
The formulations of acyclovir- Melissa nano-patch and acyclovir- Melissa cream and acyclovir nano-patch caused a reduction in the pain of lesions, compared to acyclovir routine formulation. The crusting time in acyclovir- Melissa nano-patch and cream group was less than both acyclovir groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141124020073N3
Registration date: 2022-02-20, 1400/12/01
Registration timing: retrospective

Last update: 2022-02-20, 1400/12/01
Update count: 0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Zahra Golestan nejad
Name of organization / entity
Oral medicine department associate professor
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2814
Email address
golestannejad@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
2021-09-20, 1400/06/29
Actual recruitment end date
2021-11-26, 1400/09/05
Trial completion date
empty
Scientific title
Comparison of remission index of nanofiber loading acyclovir- melisa and nanofiber loading acyclovir and mucoadhesive cream formula on Recurrent-Herpes-Labialis
Public title
Effect of acyclovir-melissa nanofiber patch in treatment of recurrent herpes labialis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Maximum interval of 48 hours since the emergence of the lesion Having a recurrent lesion (i.e., secondary) Receiving no antiviral, anti-inflammatory, steroid, or analgesic drugs Vesicular stage of the lesion and lesion size <1 cm
Exclusion criteria:
Allergies to the used herbal medicines Hepatic, renal, or systemic diseases Use of birth control pills Breastfeeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The selected patients were randomly divided into four groups. The first group received a pack containing 15 acyclovir 5%-Melissa 1% nanopatches; the second group received a tube containing acyclovir 5%-Melissa 1% cream; the third group received 15 nanopatches of acyclovir 5%; and the fourth group received acyclovir 5% cream. Considering small recruited sample size and for overall balance reasoning between the four study arms, the recruited patients were randomized employing permuted block randomization method with a block size of 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the clinicians were unaware about the content of the packages containing nanofiber patches and the creams.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of Isfahan University of Medical Sciences
Street address
Vice counselor for research and technology, Isfahan University of Medical Sciences, Hezar jerib St.
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.MUI.REC.1397.3.079

Health conditions studied

1

Description of health condition studied
Recurrent Herpes Labialis
ICD-10 code
B00.1
ICD-10 code description
Herpesviral vesicular dermatitis

Primary outcomes

1

Description
Symptoms of patient discomfort (pain, itching, burning sensation)
Timepoint
Daily measurement of the symptoms from the beginning of treatment (baseline) until the symptoms disappeared
Method of measurement
Using a numerical scale, ranging from 0 to 10

2

Description
Crusting time
Timepoint
As soon as evidence of crusting was observed in the daily images taken and sent by patients, the patient was referred for clinical examinations
Method of measurement
Clinical examination

3

Description
Healing time
Timepoint
As soon as evidence of healing was observed in the images, the patient was referred for clinical examinations
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: acyclovir-melissa nanofiber patch: Active ingredients are acyclovir in the class of antiviral drugs, and Melissa Officinalis a herb containing polyphenolic compounds with anti-inflammatory and anti-viral properties. main chemical composition consists of polyvinyl alcohol polymer, acyclovir5% and melissa1%, made in "Rahesh Daruye Novin" company, used once in a day for 5 days at the site of the lesion
Category
Treatment - Drugs

2

Description
Intervention group: acyclovir-melissa cream: Active ingredients are acyclovir5% in the class of antiviral drugs, and Melissa Officinalis1% a herb containing polyphenolic compounds with anti-inflammatory and anti-viral properties, made in "Iran Daru" pharmaceutical company, used three times in a day for five days at the site of the lesion
Category
Treatment - Drugs

3

Description
Intervention group: acyclovir nanofiber patch: Active ingredient is acyclovir in the class of antiviral drugs, main chemical composition consists of polyvinyl alcohol polymer and acyclovir, made in "Rahesh Daruye Novin" company, used once in a day for 5 days at the site of the lesion
Category
Treatment - Drugs

4

Description
Intervention group: acyclovir cream 5%, Active ingredient is acyclovir in the class of antiviral drugs, made in "Iran Daru" pharmaceutical company, used three times in a day for five days at the site of the lesion
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Zahra Golestannejad
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
golestannejad@dnt.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
aculty of Dentistry, Isfahan University of Medical Sciences, Hezar jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5512
Email
research@dnt.mui.ac.ir
Grant name
Grant code / Reference number
397079
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
zahra Golestannejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jerib st.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5515
Email
golestannejad@dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Golestannejad
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezar Jerib st
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5515
Email
golestannejad@dnt.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dorna Sarfaraz
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
105, 36th Alley, Khaghani St.
City
Isfahan
Province
Isfehan
Postal code
8175835143
Phone
+98 31 3625 4044
Email
dornasrfz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data of study participants can be shared after unidentifying individuals
When the data will become available and for how long
The access period starts from the time the results are printed
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of participants' personal data and study documents is allowed only for scientific purposes and study simulation
From where data/document is obtainable
To access the data, refer to the person in charge of updating the information.
What processes are involved for a request to access data/document
If necessary, the applicant sends an email to the person in charge of updating the information, requesting access to the data file, and the data will be sent to the applicant's email within 1 to 2 days.
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