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Evaluation of safety and the effectiveness of Prime (U+) Urea 5% Shampoo, produced by Dr. Akhavi Laboratory in improving of dryness and itching in sensitive scalp

Protocol summary

Study aim
Evaluation of safety and the effectiveness of Prime (U+) Urea 5% Shampoo, produced by Dr. Akhavi Laboratory in improving of dryness and itching in sensitive scalp
Design
Single group, phase 2, before -after clinical study. sample size is 19. The study is not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 19 volunteers with dryness and itching in scalp will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use Prime (U+) Urea 5% Shampoo produced by Akhavi laboratory for 4 weeks, at least 3 times in a week. Before intervention and 4 weeks after using changing in scalp hydration and severity of itching and burning in scalp will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female aged 18-70 years, General health, Clinical diagnosis of dry scalp, At least grade of 2 out of 10 on itching or scalp irritation, Voluntary participation and signing written informed consent Exclusion criteria: People with allergies to shampoo ingredients, Acute or chronic active disease related to scalp such as psoriasis, Lichen Planus, etc., Any type of malignancy, Pregnancy or breastfeeding
Intervention groups
Topical use of Prime (U+) Urea 5% Shampoo, Dr. Akhavi laboratory product,(Contains disodium coquil glutamate, urea, sodium lactate, chia seed oil, honeysuckle flower extract and etc...) Spray at least 3 times in a week, for 4 weeks
Main outcome variables
Change in scalp hydration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190210042676N19
Registration date: 2022-04-13, 1401/01/24
Registration timing: prospective

Last update: 2022-04-13, 1401/01/24
Update count: 0
Registration date
2022-04-13, 1401/01/24
Registrant information
Name
Aniseh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
a_samadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and the effectiveness of Prime (U+) Urea 5% Shampoo, produced by Dr. Akhavi Laboratory in improving of dryness and itching in sensitive scalp
Public title
Evaluation of safety and the effectiveness of Prime (U+) Urea 5% Shampoo, in improving of dryness and itching in sensitive scalp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 18-70 years General health Clinical diagnosis of dry scalp At least grade of 2 out of 10 on itching or scalp irritation Voluntary participation and signing written informed consent
Exclusion criteria:
People with allergies to shampoo ingredients Acute or chronic active disease related to scalp such as psoriasis, Lichen Planus, etc. Any type of malignancy Pregnancy or breastfeeding
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 19
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in research of medical school-Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-01-19, 1400/10/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1236

Health conditions studied

1

Description of health condition studied
dryness and itching in sensitive scalp
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Change in scalp hydration
Timepoint
Before intervention and 4 weeks after using
Method of measurement
Corneometry

Secondary outcomes

1

Description
Severity of itching and burning in scalp
Timepoint
Before intervention and 4 weeks after using
Method of measurement
This variable is recorded from 0 to 10 based on the patient's opinion so that 0 is sign of not itching and 10 is sign of maximum itching intensity.

Intervention groups

1

Description
Intervention group: 4 weeks using Prime (U+) Urea 5% Shampoo, Dr. Akhavi laboratory product, at least 3 times in a week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy
Full name of responsible person
Aniseh Samadi
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
dermalab@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Akhavi laboratory
Full name of responsible person
Farid Akhavi
Street address
Unit 8, No.17, Tavanir Street, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1434875419
Phone
+98 21 8879 8126
Email
info@akhavilab.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Akhavi laboratory
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
Manger of clinical study unit
Latest degree
Ph.D.
Other areas of specialty/work
Skin Biometrics
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 0880
Email
aniseh_samadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azin Ayatollahi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 7921
Email
azinay@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Clinical Research
Street address
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 0658
Email
ahmadi.maryam648@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
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
Not applicable
Data Dictionary
Not applicable
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