Evaluation of safety and effectiveness of Prim anti-dandruff line (anti-dandruff serum and shampoo and dandruff return prevention shampoo), a product of Akhavi Laboratory in the treatment of oily and dry dandruff
Evaluation of safety and effectiveness of Prim anti-dandruff line (anti-dandruff serum and shampoo and dandruff return prevention shampoo), a product of Akhavi Laboratory in the treatment of oily and dry dandruff
Design
The study is a phase 2 before-after clinical trial. The sample size is 28. The study was not randomized.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy in Tehran university of medical sciences, 28 volunteers with oily or dry dandruff of any severity will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use of Prim anti-dandruff line (anti-dandruff serum and shampoo and dandruff return prevention shampoo), a product of Akhavi Laboratory for 16 weeks once in a day. Before intervention ,4, 8 and 16 weeks after using changing in Dandruff severity will be measured. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male and female aged 18-60 years, Good general health, Oily or dry dandruff of any severity, Voluntary participation and sign the written informed consent
Exclusion criteria:
Chronic active scalp disease other than hair loss, People with allergies to serum and shampoo ingredients, Scalp surgeries
Intervention groups
Intervention group: 8 weeks of using Prim anti-dandruff serum laboratory and dry anti-dandruff shampoo produced by Akhavi as well as 8 weeks of using a mild anti-dandruff shampoo to prevent the return of dandruff
Main outcome variables
Dandruff severity based on the Adherent Scalp Flaking Score (ASFS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N14
Registration date:2021-12-14, 1400/09/23
Registration timing:prospective
Last update:2021-12-14, 1400/09/23
Update count:0
Registration date
2021-12-14, 1400/09/23
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
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 safety and effectiveness of Prim anti-dandruff line (anti-dandruff serum and shampoo and dandruff return prevention shampoo), a product of Akhavi Laboratory in the treatment of oily and dry dandruff
Public title
Evaluation of safety and effectiveness of Prim anti-dandruff line
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female aged 18-60 years
Good general health
Oily or dry dandruff of any severity
Voluntary participation and sign the written informed consent
Exclusion criteria:
Chronic active scalp disease other than hair loss
People with allergies to serum and shampoo ingredients
Scalp surgeries
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
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 of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.970
Health conditions studied
1
Description of health condition studied
hair Dandruff
ICD-10 code
ICD-10 code description
hair Dandruff
Primary outcomes
1
Description
Dandruff severity based on the Adherent Scalp Flaking Score (ASFS)
Timepoint
Before intervention, 8 and 16 weeks after the start of use
Method of measurement
Dandruff meter
Secondary outcomes
1
Description
Number of dandruff after one minute combing
Timepoint
Before intervention, 4 , 8 and 16 weeks after the start of use
Method of measurement
Dandruff Meter
Intervention groups
1
Description
Intervention group: 8 weeks of using Prim anti-dandruff serum laboratory and dry anti-dandruff shampoo produced by Akhavi as well as 8 weeks of using a mild anti-dandruff shampoo to prevent the return of dandruff
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy