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Comparison of the efficacy, safety, satisfaction and tolerability of oral N-acetil cystein Vs oral Pentoxyphilline in patients with Lichen planopillaris: A randomized controled clinical trial; assessor and analysted blinder

Protocol summary

Study aim
Efficacy, side effects, tolerability and satisfaction of treatment with pentoxifylline or N-acetylcysteine ​​in patients with lichen planoplaris Compared with the control group
Design
one envelope will be randomly selected for each patient. The letters A, B or C are inserted inside each envelope. The control group will receive 0.05% topical clobetasol solution each night with at least 30 drops to the alopecia area. The other groups in addition to the above treatment will be treated with pentoxifylline 400 mg twice daily and N-acetylcysteine ​​600 mg twice daily, respectively. LPPAI in each group at the beginning of the study, two months later and 4 months after the start of treatment and changes from baseline to the end of the study between all three groups were analyzed and evaluated. Response to treatment will be achieved if we have a 25 to 85% reduction in the LPPAI system.
Settings and conduct
Rasoul Akram Hospital, Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent, Do not have serious internal disease, Aged between 15-70, No history of serious gastrointestinal problems, There is no accompanying disease on the treatment site, The initial general Lab data of the patient do not show a serious problem. Exclusion criteria: Receiving any treatment during the last month, Positive history of gastrointestinal cardiovascular disease and malignancies, Pregnant and lactating people, Consumption of any medication that interferes with the medications received in this study, Accompaniment of the disease with the generalized form of skin lichen planus or the form of mucosal erosion
Intervention groups
Clobetasol solution , Clobetasol solution+ pentoxifylline and Clobetasol solution+ N-acetylcysteine
Main outcome variables
Lichen planoplaris activity index, complications, tolerability, satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210208050292N1
Registration date: 2021-04-02, 1400/01/13
Registration timing: registered_while_recruiting

Last update: 2021-04-02, 1400/01/13
Update count: 0
Registration date
2021-04-02, 1400/01/13
Registrant information
Name
Hossein Ahmadi Kahjoogh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3741 7015
Email address
hossein.ak31@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy, safety, satisfaction and tolerability of oral N-acetil cystein Vs oral Pentoxyphilline in patients with Lichen planopillaris: A randomized controled clinical trial; assessor and analysted blinder
Public title
Comparison of oral N-acetil cystein Vs oral Pentoxyphilline in patients with Lichen planopillaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Do not have serious internal disease. Aged between 15-70 No history of serious gastrointestinal problems. There is no accompanying disease on the treatment site The initial general Lab data of the patient do not show a serious problem
Exclusion criteria:
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method will be used to perform the randomization process. The patients will be divided into three groups using Cards or envelop shuffling method.
Blinding (investigator's opinion)
Double blinded
Blinding description
All assessments and analyzes will be performed by blind people other than the main researchers.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
10th Alley, Niayesh Ave, 16th West Ave, Sahand Town
City
Maragheh
Province
East Azarbaijan
Postal code
5518937747
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.IUMS.FMD.REC.1399.336

Health conditions studied

1

Description of health condition studied
Lichen planopilaris
ICD-10 code
L66.1
ICD-10 code description
Lichen planopilaris

Primary outcomes

1

Description
To facilitate statistical comparison of the study results, the lichen planopilaris activity index scoring system (LPPAI) introduced by Chiang in 2010 will be used. In this system, 8 signs and symptoms of the disease are scored, including Itching, burning, pain, erythema, pre-follicular erythema, pre-follicular scale, anagen pull test and disease spreading.each criteria will be scored from 0 to 3:Thus, 0:lack of sign/symptom, 1:the mild sign/symptom, 2:the moderate sign/symptom and 3:the severe sign/symptom. In agagen pull test, zero score shows the result is negative and it is positive when the score is one. In spreading score, zero score shows no spreading, 1:moderate spreading and 2: sever spreading. The total score according to the following formula will be 0 to 10: LPPAI (0 to 10) = (itching + burning + pain) / 3 + (scalp erythema + pre-follicular erythema + pre-follicular shell) / 3 + 2.5 (anagen pull test)+1/5(spreading/ 2).The tolerability of the treatment will be measured by asking the patients (yes / no) and the satisfaction of the treatment will be evaluated by a Likert scoring. Patients will be asked about the possible side effects of the drugs used in each appointment session (basic visit, second and fourth month).
Timepoint
At the beginning of the study (before the intervention), 2 and 4 months after the intervention
Method of measurement
Lichen planopilaris activity index score: A questionnaire for assessing the severity of lichen planoplaris disease, which was developed and reported in 2010 by Chiang. Complications: Patient response based on Likert scale. Tolerance: Patient response based on Likert scale. Satisfaction: Patient response based on Likert scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention groups in addition to the control treatment will be treated with pentoxifylline 400 mg twice daily and N-acetylcysteine ​​600 mg twice daily, respectively. LPPAI in each group at the beginning of the study, two months later and 4 months after the start of treatment and changes from baseline to the end of the study between all three groups were analyzed and evaluated. Response to treatment will be achieved if we have a 25 to 85% reduction in the LPPAI system.The control group will receive 0.05% topical clobetasol solution each night with at least 30 drops to the alopecia area.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Hossein Ahmadi Kahjoogh
Street address
Rasool Akram hospital, Maziar Mansoori Ave, Sattar khan Blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
hossein.ak31@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motavallian
Street address
Iran university of medical scinence, Hemmat Exp
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hossein Ahmadi Kahjoogh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
10th Alley, Niayesh Ave, 16th West Ave, Sahand Town
City
Maragheh
Province
East Azarbaijan
Postal code
5518937747
Phone
+98 41 3741 7015
Fax
Email
hossein.ak31@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Ahmadi Kahjoogh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
10th Alley, Niayesh Ave, 16th West Ave, Sahand Town
City
Maragheh
Province
East Azarbaijan
Postal code
5518937747
Phone
+98 41 3741 7015
Fax
Email
hossein.ak31@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Ahmadi Kahjoogh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
10th Alley, Niayesh Ave, 16th West Ave, Sahand Town
City
Maragheh
Province
East Azarbaijan
Postal code
5518937747
Phone
+98 41 3741 7015
Fax
Email
hossein.ak31@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
They will be published on the scientific journals
When the data will become available and for how long
From 2022 onwards
To whom data/document is available
It will be accessable for everyone
Under which criteria data/document could be used
Raw data will not be published
From where data/document is obtainable
Scintific websites
What processes are involved for a request to access data/document
By sending emaile to the researcher
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