Evaluating the Effectiveness of Lipid Nanostructures Containing Lavender Essential Oil Compared to 2% Minoxidil in Androgenic Hair loss
Design
Controlled Clinical trial, with Parallel group, Unblinded and Non-Randomized, Phase 2 and 3 on 20 Patients
Settings and conduct
Male individuals who refer to Sina Hospital in Tabriz with Symptoms of Frontal-temporal Hair loss will be Included in the Study if they agree and meet the Eligibility Criteria (Inclusion Criteria). Volunteers will be Instructed on the Correct Use (The Study is not Blinded). In a Symmetrical manner, Minoxidil 2% will be Used on One side of the Head and a Formulation of Lipid Nanostructures containing Lavender Essential oil on the other side. Necessary Photographs will be taken before the Start, 12 Weeks after the Start, and After the End of the Intervention, and then the Images will be Analyzed by a Physician.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male Subjects with progressive Hair loss in the Fronto-temporal Region.
Exclusion criteria: Any Manifestation of Skin Disease in the Study area, Allergy to Pharmaceutical Products or Components of the Study Product, History of Skin Cancer, Acute or Chronic Disease that could interfere with the Study, use of Topical or Systemic Medications or Cosmetic Products that could interfere with the Study.
Intervention groups
Intervention group: Lavender Essential oil contains Compounds that Increase Hair growth and Hair Density. The Duration of the Intervention is 24 weeks, in which on One Side, the Formulation of Lipid Nanostructures of Lavender Essential oil is used one Night a week in an Amount of 1 cc in an Area of 1 cm in Diameter that has been previously Determined. Control group: Minoxidil 2% will be Used once a Day in an Amount of 1 cc in an Area of 1 cm in Diameter.
Main outcome variables
Percentage Change in Hair Density per unit of selected Area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241015063373N1
Registration date:2025-01-08, 1403/10/19
Registration timing:retrospective
Last update:2025-01-08, 1403/10/19
Update count:0
Registration date
2025-01-08, 1403/10/19
Registrant information
Name
Mahsa Farshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3288 1744
Email address
farshidimahsa8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-31, 1403/08/10
Expected recruitment end date
2024-11-07, 1403/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Nanostructured Lipid Carriers Containing Lavender Essential Oil Compared to 2% Minoxidil for Androgenic Hair loss; Clinical Trial
Public title
Effect of Lavender Essential Oil Formulation on Hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male Sex
Progressive Symptoms of Hair loss in the Frontotemporal Area
Exclusion criteria:
Any Manifestation of Skin Disease in the Study Area
Allergy or Hypersensitivity Reaction to Medicinal Products or Components of the Study Product
History of Skin Cancer
Acute or Chronic Disease that could Interfere with the Study
Use of Topical or Systemic Medications or Cosmetic Products that could Interfere with the Study
Age
From 25 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Lipid Nanostructures Containing Lavender Essential Oil are applied to One Side of the Scalp and 2% Minoxidil is applied to the Opposite Side of the Scalp.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Pharmacy-Tabriz University of Medical Sciences
Street address
Medical Sciences Research Committee of Tabriz, Attar neyshabouri Ave., Golgasht Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2024-09-29, 1403/07/08
Ethics committee reference number
IR.TBZMED.PHARMACY.REC.1403.039
Health conditions studied
1
Description of health condition studied
Androgenic Alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Percentage Change in Hair Density per unit of Specified Scalp Area
Timepoint
Before the Start of the Intervention, 12 Weeks after the Start of the Intervention, immediately after the End of the Intervention (24 weeks)
Method of measurement
Dermatoscope Device, Yinama Model, Made in China
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the Intervention Group, Lipid Nanostructure Formulation Containing Lavender Essential Oil will be used. In order to prepare Lipid Nanostructures, a High-speed Homogenization Method is used using a Homogenizer. The Formulation of Lipid Nanostructures Containing Lavender Essential Oil is made in the Laboratory of the Tabriz Faculty of Pharmacy. To prepare this Formulation, 400 mg of Lavender Essential oil as a Liquid Phase, 600 mg of Precirol as a Solid Phase, and 250 mg of Ploxamer as a Surfactant are used. (The Steps of Producing Lipid Nanostructures are briefly written.) Lavender essential Oil contains Compounds that cause the Expression of Factors that Increase Hair Growth and Hair Density. The Intervention Period is 24 weeks, in which 2% Minoxidil Manufactured by Pak Darou Company is used on One Side and a Formulation of Lipid Nanostructures Containing Lavender Essential Oil is used on the Other side at Two Symmetrical Points on the Head. The Desired Formulation will be applied One Night a week in an Amount of 1 cc in a Pre-determined Area of 1 cm in Diameter. The necessary Photographs will be taken by Dermatoscope at times Zero, 12 weeks and 24 weeks after the Start, and the Images will be analyzed by the Doctor.
Category
Treatment - Drugs
2
Description
Control group: In the Control group, 2% Minoxidil, a Product of Pak Darou Company, will be used Once daily. 2% minoxidil will be applied once every Night in an Amount of 1 cc in a Pre-determined Area of 1 cm in Diameter. The Intervention Period is 24 weeks, and Imaging is performed at times Zero, 12 weeks, and 24 weeks after the Start of the Intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pharmaceutical Research Center - Sinai Hospital
Full name of responsible person
Mahsa Farshidi
Street address
Sina Hospital , Hafez Ave. / Pharmaceutical Research Center , Golgasht Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5184836533
Phone
+98 41 3288 1744
Email
Farshidimahsa8@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr, Parviz Shahabi
Street address
Tabriz university of Medical Sciences , Attar Neyshaouri Ave., Golgasht Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Phone
+98 41 3335 5921
Fax
Email
info@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Farshidi
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz faculty of Pharmacy, Attar Neyshabouri Ave., Golgasht Blvd.,
City
Tabriz
Province
East Azarbaijan
Postal code
5184836533
Phone
+98 41 3288 1744
Email
farshidimahsa8@gmal.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Farshidi
Position
Student of pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz faculty of Pharmacy, Attar neyshabouri Ave., Golgasht Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5184836533
Phone
+98 41 3288 1744
Fax
Email
Farshidimahsa8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Farshidi
Position
Student of pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz university of Medical Sciences , Attar Neyshaouri Ave., Golgasht Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5184836533
Phone
+98 41 3288 1744
Fax
Email
Farshidimahsa8@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
Undecided - It is not yet known if there will be a plan to make this available
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available