Efficacy and safety evaluation of the cream including Citystem extract derived from Marrubium vulgare plant and Phytessence extract derived from Phytessence peach flower on reducing skin damage caused by air pollution
Efficacy and safety evaluation of the cream including Citystem extract derived from Marrubium vulgare plant and Phytessence extract derived from Phytessence peach flower on reducing skin damage caused by air pollution
Design
Clinical trial is two parallel group, two blinded side, phase 3 in 26 people. Balance Blocked Randomization in size 4.The randomization sequence is prepared by a statistician. Based on the specified randomized sequence, it places the participant into treatment groups and provides them with the drugs that have been tagged with the specific code of each participant.
Settings and conduct
The study is a parallel evaluation of efficacy and safety of a cream including Citystem extract derived from Marrubium vulgare plant and Phytessence extract derived from Phytessence peach flower on reducing skin damage caused by air pollution on healthy volunteer in Center For Research and Training in skin Diseases and Leprosy. The study is double blinded and Center researchers and participants will be unaware of the study sequence.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Signing the infirmed consent form and agree to regularly attend follow-up courses, 18 -50 years old men and women, Exposure to the outside air (at least one hour in a day)
Exclusion criteria:
People with any kind of skin disease, Suffering from a chronic disease affecting the skin condition (diabetes, thyroid diseases,...), Smoking, Pregnancy or lactation
Intervention groups
Intervention group:Using twice a day (morning and night) the cream containing Citystem extract derived from Marrubium vulgare plant and Phytessence extract derived from Phytessence peach flower plant protects the skin for 8 weeks
Control group:Using a placebo cream twice a day with the same smell, color and shape as the cream of the intervention group for 4 weeks
Main outcome variables
Trance epidermal water lost (TEWL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161207031288N14
Registration date:2022-11-26, 1401/09/05
Registration timing:registered_while_recruiting
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Saman Ahmad Nasrollahi
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 8190
Email address
snasrollahi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety evaluation of the cream including Citystem extract derived from Marrubium vulgare plant and Phytessence extract derived from Phytessence peach flower on reducing skin damage caused by air pollution
Public title
Efficacy and safety evaluation of the cream including Citystem extract and Phytessence extract on reducing skin damage caused by air pollution
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing the infirmed consent form and agree to regularly attend follow-up courses
18 -50 years old men and women
Exposure to the outside air (at least one hour in a day)
Exclusion criteria:
People with any kind of skin disease
Suffering from a chronic disease affecting the skin condition (diabetes, thyroid diseases,...)
Smoking
Pregnancy or lactation
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Balance Blocked Randomization in size 4. An online site (https://www.sealedenvelope.com) will be used to generate a randomized list of study groups. According to the random block method and considering the four blocks, 7 blocks will be produced for 26 patients. Finally, 2 samples are removed to reach 26 patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Center researchers and participants will be unaware of the study sequence. After confirming new participant to the study and registering the participant code, the study coordinator who is located on the participant recruitment site. Based on the specified randomized sequence and places the participant into treatment groups. and provides them with the drugs that have been tagged with the specific code of each participant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TUMS.TIPS.REC.1400.175
Health conditions studied
1
Description of health condition studied
Skin damage caused by air pollution
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Trance epidermal water lost (TEWL)
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
MPA 580(Multi Probe Adaptor) device
Secondary outcomes
1
Description
Skin PH
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
MPA 580(Multi Probe Adaptor) device
2
Description
Skin erythema
Timepoint
Before the study, 4 and 8 weeks after the intervention
Method of measurement
MPA 580(Multi Probe Adaptor) device
Intervention groups
1
Description
Intervention group:Using twice a day (morning and night) the cream containing Citystem extract derived from Marrubium vulgare plant and Phytessence extract derived from Phytessence peach flower plant protects the skin for 8 weeks
Category
Treatment - Drugs
2
Description
Control group:Using a placebo cream twice a day with the same smell, color and shape as the cream of the intervention group for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Street address
415, Taleghani Avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotouhi
Street address
6th floor,Ghods St.,Keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
research@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saman Ahmad Nasrollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
415, Taleghani St.,Naderi St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
samannasrol@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Proffesor of Dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
415, Taleghani St.,Naderi St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
firozali@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi Street, Taleqani Avnue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available