Protocol summary

Study aim
Comparison of the Efficacy of Pharmacological Therapy and Alex Laser Therapy in Treating Dark Circles Under the Eyes in Patients Complaining of Dark Circles at a Dermatology Clinic in Tehran in 2024.
Design
This clinical trial consists of two comparative groups undergoing treatment with laser therapy and topical medication, featuring parallel groups and a single-blind design. The allocation of participants to the groups was performed non-randomly. This is a Phase 2 study involving a total of 102 patients.
Settings and conduct
This clinical trial will involve 102 patients with periorbital hyperpigmentation, divided into two groups of 51. Participants will be unaware of each other's conditions. One group will receive four sessions of Alexandrite laser therapy at one-month intervals, while the other group will apply a modified Kligman formula nightly for six months, consisting of 0.1% betamethasone, 5% hydroquinone, and 0.05% tretinoin. The degree of hyperpigmentation will be assessed before and after treatment. Additionally, patient satisfaction with both treatment modalities will be evaluated and compared.
Participants/Inclusion and exclusion criteria
In general, patients presenting with complaints of dark circles under the eyes at the dermatology clinic who consent to participate in the study will be included. Those who express unwillingness to continue their participation or experience a severe medical adverse event will be withdrawn from the study.
Intervention groups
In this study, two types of interventions will be conducted in two distinct groups for the treatment of infraorbital hyperpigmentation. One group will undergo treatment with Alexandrite laser for a total of four sessions in the under-eye area, while the other group will utilize topical medications nightly for a duration of six months.
Main outcome variables
Efficacy comparison of methods for infraorbital hyperpigmentation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241018063404N1
Registration date: 2025-01-08, 1403/10/19
Registration timing: registered_while_recruiting

Last update: 2025-01-08, 1403/10/19
Update count: 0
Registration date
2025-01-08, 1403/10/19
Registrant information
Name
Sama Khoraminejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 2168
Email address
s.khoraminejad@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-08-01, 1404/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Alexandrite laser therapy versus medical therapy for the treatment of infraorbital dark circles in patients of dermatology clinic
Public title
Comparison of the efficacy of laser therapy versus medical therapy for the treatment of infraorbital dark circles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having darkness under the eyes referring to the skin clinic Consent to participate in the study
Exclusion criteria:
Refusal to continue participating in the study Severe medical complication
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a single-blind method has been used. In this approach, participants are unaware of the group allocation. This design was intentionally implemented to prevent any potential bias or psychological influence in the assessment of outcomes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653959564
Approval date
2024-10-09, 1403/07/18
Ethics committee reference number
IR.IAU.TMU.REC.1403.302

Health conditions studied

1

Description of health condition studied
Infraorbital dark circles
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Infraorbital pigmentation score
Timepoint
Measurement of under-eye pigmentation was conducted at the onset of the study (prior to the initiation of the intervention) and again six months following the commencement of treatment.
Method of measurement
Measurement of pigmentation device; Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group One: The first intervention group consists of 51 individuals who presented with complaints of dark circles under the eyes at Dr. Tehrani's dermatology clinic in Tehran. This group will receive treatment using the Alexandrite laser from Cynosure Elite, an American-made device operating at a wavelength of 755 nm. Participants in this group will undergo treatment over four sessions, spaced 1.5 months apart. During the treatment period, participants will be permitted to use only under-eye sunscreen.
Category
Treatment - Devices

2

Description
Intervention group Two: Intervention Group Two: The second intervention group comprises 51 individuals who presented with complaints of dark circles under the eyes at Dr. Tehrani's dermatology clinic in Tehran. This group will receive treatment with a modified formulation of the Kligman formula, consisting of a 0.1% betamethasone cream, a 5% hydroquinone cream and a 0.05% tretinoin cream. Participants are required to apply a lentil-sized amount of this topical combination under the eyes every night for a duration of six months. Throughout the treatment period, participants will be permitted to use only the prescribed medications and an under-eye sunscreen.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic of Dr. Tehrani
Full name of responsible person
Sepideh Tehrani
Street address
Unit 19, 4th Floor, Building 2, Corner of Sarv Alley, Between Mirdamad and Zafar Streets, Jordan Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1968645744
Phone
+98 21 8878 8919
Email
Tehrani۴۲۶۴۳@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
University of Azad Medical Sciences, Corner of Gol Yakh Street and Ayneh Boulevard, Amir Pabargah Street, Qolhak Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2642 2660
Email
alisamiee777879@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Sama Khoraminejad
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653959564
Phone
+98 21 7788 2168
Fax
Email
s2000.edu.khoram@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sama Khoraminejad
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653959564
Phone
+98 21 7788 2168
Fax
Email
s2000.edu.khoram@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sama Khoraminejad
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
3th Floor, No. 48, Shahid Maleki Alley, West 160 St., Rashid Ave., Tehran Pars
City
Tehran
Province
Tehran
Postal code
1653959564
Phone
+98 21 7788 2168
Fax
Email
s2000.edu.khoram@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The individual data of participants in this study will be shared only after ensuring that the identities of individuals are rendered unidentifiable, thereby preserving the privacy of all participants.
When the data will become available and for how long
The dissemination of these documents/data files will occur upon the complete conclusion of the research project. In the event that the project is published as a manuscript, access to the data will be granted following the completion of the publication process, and will remain available for a period of up to two years after the article's publication.
To whom data/document is available
Due to the practical relevance of the project's subject matter in the fields of medicine, industry, and aesthetics, access will be granted to individuals who submit requests and are approved and deemed qualified by the project team.
Under which criteria data/document could be used
Any utilization of the data from this study must be coordinated with the project team responsible for its execution and accompanied by a written permission statement from the research team to ensure the preservation of publication rights.
From where data/document is obtainable
Applicants may contact us via email at the following address (or at a subsequently provided address in the event of any changes): s2000.edu.khoram@gmail.com.
What processes are involved for a request to access data/document
Initially, you are required to introduce yourself and your research group in your email. Following this, please provide a comprehensive description of how the data will be utilized and the specific methodologies involved. It is essential to clearly and explicitly articulate the objectives of using the data. Subsequently, necessary arrangements will be coordinated with you by the project team.
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