Determining the effectiveness of turmeric extract in brightening lip color
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 2-3 in 56 patients
Settings and conduct
This study is a interventional study that is performed on patients referred to the dermatology clinic of the Great Prophet Hospital with a complaint of dark lips. Individuals are randomly divided into two groups. One group is selected as a control and one group as an intervention group . The intervention (case)group is given a therapeutic product that is a curcumin-based lip balm and the control group is given a curcumin-free lip balm. Lip balm should be rubbed on the lips every 4 hours. All individuals in both groups are monitored monthly by lip imaging for 6 months and the results are recorded. Participants are continuously monitored and in case of any side effects, the product is stopped.
Participants/Inclusion and exclusion criteria
Entry conditions: dark lips and completely healthy lip skin before the study
No entry conditions:1. Presence of skin lesions or any sores or inflammation on the lips before the study 2. History of allergic reaction to curcumin
Intervention groups
The intervention group is given a therapeutic product that is a curcumin-based lip balm and the control group is given a curcumin-free lip balm. Lip balm should be rubbed on the lips every 4 hours.
Main outcome variables
Lip lightness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211111053038N1
Registration date:2022-06-22, 1401/04/01
Registration timing:retrospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Reyhaneh Pasandipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3368 1176
Email address
reyhane.pasandipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of turmeric extract(Curcumin) in brightening lip color
Public title
Evaluation of the effectiveness of turmeric extract(Curcumin) in brightening lip color
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
dark lips
completely healthy lip skin before the study
Exclusion criteria:
Presence of skin lesions or any sores or inflammation on the lips before the study
history of Allergic reaction to curcumin
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The study is a simple one-way blind randomized clinical trial that 56 patients were randomly selected by simple sampling method among patients with dark lips who referred to the skin clinic of the Payambar Azam in Bandar Abbas after examining the inclusion and exclusion criteria. For the first step we prepare 56 similar small packages. In 28 packs we put a paper named A and in the other 28 packs we put papers named B, the patients don’t know the content of packs. At the patient entrance let them to choose one pack randomly from all mixed 56 packs and give the chosen pack to doctor. The doctor will start the treatment based on the package name which is A(case group) or B(control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants of the control group are blind as receiving a therapeutic product without the substance evaluated in the study (curcumin). This group receives lip balm without curcumin
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Hormozgan University of Medical Science
Street address
Hormozgan university of medical science , Chamran blvd
City
BandarAbbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-09-05, 1400/06/14
Ethics committee reference number
IR.HUMS.REC.1400.257
Health conditions studied
1
Description of health condition studied
Dark Lip Color
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of lightening of lip color due to curcumin
Timepoint
Lip imaging at the beginning of the study and then every month for 6 months
Method of measurement
Mobile phone imaging and lip color comparison from the beginning to the end of the study
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: . The intervention group is given a therapeutic product that is a curcumin-based lip balm . For 6 months lip balm should be rubbed on the lips every 4 hours
Category
Treatment - Drugs
2
Description
Control group: control group is given curcumin-free lip balm. Lip balm should be rubbed on the lips every 4 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Payambar Aazam hospital
Full name of responsible person
Sedigheh Tavakoli
Street address
Payambar Aazam hospital, infront of Farhangian alley
City
BandarAbbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sedigheh Tavakoli
Street address
Payambar Aazam hospital, Jomhouri Eslami blvd
City
BandarAbbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Email
dr.tavakoli_s@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
reyhaneh pasandipour
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.4, Koosha2 alley , Koosha st
City
Bandarabbas
Province
Hormozgan
Postal code
7915944769
Phone
+98 76 3368 1176
Email
reyhane.pasandipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sedigheh Tavakoli
Position
dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Hormozgan university of medical science, Chamran Blvd
City
BandarAbbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
dr.tavakoli_s@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Reyhaneh Pasandipour
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.4, Koosha 2 alley, Koosha st, north Golshahr
City
BandarAbbas
Province
Hormozgan
Postal code
79159769
Phone
+98 76 3368 1176
Email
reyhane.pasandipour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main consequence of the study is that it can be shared without identifying individuals
When the data will become available and for how long
Access started 6 months after the end of the study
To whom data/document is available
Researchers working in academic and scientific institutions and the pharmaceutical industry
Under which criteria data/document could be used
Beauty researchers and pharmacists
From where data/document is obtainable
dr sedigheh tavakoli, Hormozgan university of medical science, bandarabbas
00987633333280
What processes are involved for a request to access data/document