Protocol summary
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Study aim
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Examining the effects of Anaheal Plus supplement on the healing of acne scars, Examining the change in the surface of acne spots with Anaheal Plus, Examining the change in inflammation caused by acne with Anaheal Plus, Examining the change in the number of lesions caused by acne scars with Anaheal Plus
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Design
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Clinical trial with control group, based on community and practical, on 50 patients
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Settings and conduct
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The method of conducting this study will be a clinical trial and the participating patients will be selected from the patients of the clinics and hospitals of Tehran Islamic Azad University.
After receiving Anaheal Plus supplement by the first group and receiving placebo by the second group, both groups will be examined at the end of the study in terms of changes in the level and intensity of the spots caused by acne, as well as the number of acne lesions and the degree of inflammation and redness of the lesions.
The informed consent form prepared in advance will also be provided to the patients so that they are fully familiar with the study process.
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Participants/Inclusion and exclusion criteria
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Patients over 18 years old with acne scars
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Intervention groups
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50 patients above 18 years with acne scars who have been confirmed by a dermatologist will be selected and half of these people, who will be placed in the intervention group by using a random number table, will receive A H A exfoliator and Anaheal Plus supplement for one month.
Considered variables will be checked one month after the start of the treatment. The rest of the studied patients will be in the control group and will receive A H A exfoliator like the intervention group, with the difference that they will receive placebo instead of Anaheal plus.
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Main outcome variables
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Number of lesions, Area of the scar, Inflammation, Redness
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150706023084N17
Registration date:
2023-08-22, 1402/05/31
Registration timing:
prospective
Last update:
2023-12-03, 1402/09/12
Update count:
1
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Registration date
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2023-08-22, 1402/05/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-09-23, 1402/07/01
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Expected recruitment end date
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2023-12-22, 1402/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Study of the effects of Anaheal plus supplement on inflammation and scarring caused by acne
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Public title
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Anaheal plus effect on acne
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Acne scarring
Age range over 18 years
Exclusion criteria:
Allergy to pineapple, curcuma, celery, carrot and fennel
Pregnancy
Lactation
Renal failure (GFR<30)
liver failure (Child pugh B,C)
Hemophillia
Using two antiplatelet drug
Using one anti platelet and one anti coagulant drug
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To randomize the study, each patient is assigned a code (1 or 2) using Rand number. Conventionally, the patient who received code one will receive drug and the patient who received code two will receive placebo. It should be noted that the patients will not know what code they have received and only the researcher will be aware of this issue.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study will be Single blinded in such a way that the participants will not be aware of the contents of the medicine package they receive. A code will be assigned to each patient using a Rand number. Patients whose code is 1 will receive the drug, and patients who are assigned a code of 2 will receive a placebo.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-24, 1402/03/03
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Ethics committee reference number
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IR.IAU.PS.REC.1402.100
Health conditions studied
1
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Description of health condition studied
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Acne
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ICD-10 code
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L70
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ICD-10 code description
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Acne
Primary outcomes
1
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Description
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The number of lesions caused by acne scars
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Timepoint
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30 days
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Method of measurement
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Observational
2
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Description
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Area of scar caused by acne
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Timepoint
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30 days
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Method of measurement
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Measure with a ruler
3
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Description
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Inflammation
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Timepoint
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30 days
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Method of measurement
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According to dermatologist opinion
4
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Description
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Redness
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Timepoint
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30 days
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Method of measurement
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According to dermatologist opinion
Intervention groups
1
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Description
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Intervention group: 25 patients above 18 years with acne scars who have been confirmed by a dermatologist will be selected and receive A H A exfoliator once a day on the areas which have acne scars and also they will consume Anaheal Plus supplement which contains bromelain and curcumin and is produced by Salamat parmoon amin pharmaceutical Co. two times a day (One in the morning and one in the evening) for one month. Considered variables will be checked one month after the start of the treatment.
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Category
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Treatment - Drugs
2
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Description
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Control group:25 patients will be in the control group and will receive A H A exfoliator like the intervention group, with the difference that they will receive placebo capsule which is produced by Salamat parmoon amin pharmaceutical Co. twice a day for one month instead of Anaheal plus.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Salamat Parmoon Amin Pharmaceutical company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data are collected in the form of a questionnaire
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When the data will become available and for how long
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After the intervention
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To whom data/document is available
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Qualified persons
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Under which criteria data/document could be used
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Used for scientific advancement in the field under study
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From where data/document is obtainable
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Clinical office of Islamic Azad University,Medical science of Tehran, Faculty of pharmacy
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What processes are involved for a request to access data/document
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Request in writing by going through legal procedures
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Comments
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