Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand, a product of Vera Rahesh Pharmed Company in repairing and improving the appearance of damaged hair compared to placebo.
Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand in repairing and improving the appearance of damaged hair compared to placebo.
Design
The study is a phase 2-3 clinical trial, cross over, randomized and double-blind comparison with placebo. Randomization is done simply using block randomization.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 14 volunteers will be selected and enrolled in the study after signing consent form. Volunteers are taught to use of iDR brand hair spray and mask after bathing for two weeks or a placebo. Blinding the participants will be such that both products will be packed in the same containers, that are distinguished from each other only by code number on the packaging. In order to blind the outcome assessor, the randomization list will be provided to a third person and the allocation of formulations to each of the participants will be done after receiving the random code. Before intervention, 30 minutes after using and 2 weeks after not using changing in Hair shining will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: female aged 18-55 years, Good general health,Voluntary participation and sign the written informed consent.
Exclusion criteria: Pregnancy and breastfeeding.
Intervention groups
ntervention group: Using iDR brand hair spray and mask after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of the product should be used on the hair. After 5 minutes, use two puffs of iDR hair mask on the hair and avoid washing it.
Control group: Using spray with the same packaging as the original product containing normal saline and mask without active ingredients after bathing for two weeks, at least 4 times
Main outcome variables
Hair shine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050179N8
Registration date:2023-12-27, 1402/10/06
Registration timing:registered_while_recruiting
Last update:2023-12-27, 1402/10/06
Update count:0
Registration date
2023-12-27, 1402/10/06
Registrant information
Name
Taraneh Yazdanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
drtaraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-27, 1402/10/06
Expected recruitment end date
2024-08-27, 1403/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand, a product of Vera Rahesh Pharmed Company in repairing and improving the appearance of damaged hair compared to placebo.
Public title
Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand in repairing and improving the appearance of damaged hair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female aged 18-55 years.
Good general health
People with damaged hair naturally or after using hair color, including tangles, frizz, frizz, dullness.
Voluntary participation and sign the written informed consent.
Exclusion criteria:
People with known allergies to mask or spray ingredients
Active acute or chronic scalp disease such as psoriasis, lichen planus, etc.
Having any type of malignancy
Scalp surgeries
Pregnancy and breastfeeding
Change in shampoo used or supplements taken such as zinc and vitamin C during the study.
Using 2 in 1 shampoo containing softener, hair ointment, hair gel or tuft during the study
Age
From 18 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
14 people are assigned to one of AB, BA sequences using block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
The physician and expert evaluating the results and the participants are unaware of the type of products offered in each cycle. Blinding the participants will be such that both products will be packed in the same containers, that are distinguished from each other only by code number on the packaging. In order to blind the outcome assessor, the randomization list will be provided to a third person and the allocation of formulations to each of the participants will be done after receiving the random code.
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
2023-12-12, 1402/09/21
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.127
Health conditions studied
1
Description of health condition studied
hair damage
ICD-10 code
L67
ICD-10 code description
Hair color and hair shaft abnormalities
Primary outcomes
1
Description
Hair shine
Timepoint
Before intervention, 30 minutes and two weeks after use
Method of measurement
By Glossymeter probe from the device Multi Probe Adapter (MPA)
Secondary outcomes
1
Description
Number of people in improved or better condition
Timepoint
Before intervention, 30 minutes and two weeks after use
Method of measurement
Based on GAIS criteria: 0 = worse than baseline pretreatment appearance, 1 = no change, 2 = improved, 3 = much improved, 4 = excellent improvement
2
Description
The level of satisfaction of consumers in general and also separately for each of the parameters of hair softness, hair manageability, easy to comb and maintaining shine.
Timepoint
Before intervention, 30 minutes and two weeks after use
Method of measurement
based on not at all satisfied (-2), not satisfied (-1), not having a particular opinion (0), almost satisfied (1), very satisfied (2)
Intervention groups
1
Description
Intervention group: Using iDR brand hair spray and mask after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of the product should be used on the hair. After 5 minutes, use two puffs of iDR hair mask on the hair and avoid washing it.
Category
Treatment - Drugs
2
Description
Control group: Using spray with the same packaging as the original product containing normal saline after bathing for two weeks, at least 4 times. Depending on length and volume of the hair, one to three milliliters of hair mask with mask base composition, without active ingredients on the hair and avoid washing it.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy