Comparative Study of Hyaluronic Acid Microneedle patches vs. Topical Hyaluronic Acid for Improvement of Facial Skin Hydration and Elasticity
Design
A Two-Arm, phase 2, randomized, active controlled, split face, clinical study. sample size is 20. The study is not randomized. Randomization is done by simple randomization using a blind card.In this way, the name of the formulation is written on the same card. A card is selected randomly for each region.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 Cases of aging skin, fine lines and wrinkles around the eyes with mild to moderate grade will be selected and enrolled in the study after signing consent form. Before intervention, 4 and 12 weeks after using changing in skin elasticity ,skin hydration and depth, area and volume of periorbital area will be measured. This study is one-way blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male or female aged 30-60 years
People with aging skin, fine lines and wrinkles around the eyes with grades 3 and 4 (mild to moderate) according to the Fitzpatrick classification
Signed informed consent knowingly
Exclusion criteria:
Sensitivity to hyaluronic acid or standard formulation ingredients
Using invasive skin treatments such as laser or Botox in the past 6 months.
Active skin infection or disease.
Pregnancy or lactation
Intervention groups
Intervention group: Injectable Hyaluronic acid microneedles . Contains: Hyaluronic Acid: A mix of low and high molecular weights. Once in a week for 4 weeks.
Control group: Topical treatment with Vitalier hyaluronic skin serum, 30 ml, daily
Main outcome variables
Skin elasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042676N46
Registration date:2025-08-10, 1404/05/19
Registration timing:prospective
Last update:2025-08-10, 1404/05/19
Update count:0
Registration date
2025-08-10, 1404/05/19
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
2025-09-23, 1404/07/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Hyaluronic Acid Microneedle patches versus Topical Hyaluronic Acid for Improvement of Facial Skin Hydration and Elasticity
Public title
Comparative Study of Hyaluronic Acid Microneedle patches vs. Topical Hyaluronic Acid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 30-60 years
People with aging skin, fine lines and wrinkles around the eyes with grades 3 and 4 (mild to moderate) according to the Fitzpatrick classification
Signed informed consent knowingly
Exclusion criteria:
Sensitivity to hyaluronic acid or standard formulation ingredients
Using invasive skin treatments such as laser or Botox in the past 6 months.
Active skin infection or disease.
Pregnancy or lactation
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization using a blind card.In this way, the name of the formulation is written on the same card. A card is selected randomly for each region.
Blinding (investigator's opinion)
Single blinded
Blinding description
In case of assessor blinding, the randomization list is given to a third person. Assignment of the formulation to the treatment sites of participants is made after receiving the code of randomization by researcher.
Placebo
Not 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 1-219
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2025-08-03, 1404/05/12
Ethics committee reference number
R.TUMS.TIPS.REC.1404.055
Health conditions studied
1
Description of health condition studied
periorbital wrinkle, dark circle
ICD-10 code
R23.4
ICD-10 code description
Changes in skin texture
Primary outcomes
1
Description
Skin elasticity
Timepoint
Before intervention, 4 and 12 weeks after intervention
Method of measurement
Cutometery
Secondary outcomes
1
Description
Depth, area and volume of periorbital area
Timepoint
Before intervention, 4 and 12 weeks after intervention
Method of measurement
Visioface camera
2
Description
Skin hydration changes of periorbital area
Timepoint
Before intervention, 4 and 12 weeks after intervention
Method of measurement
Corneometery by MPA580
Intervention groups
1
Description
Intervention group: Injectable Hyaluronic acid microneedles . Contains: Hyaluronic Acid: A mix of low and high molecular weights. Once in a week for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Topical treatment with Vitalier hyaluronic skin serum, 30 ml, daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy,Tehran University of Medical Sciences