Periorbital HyperpigmentationNCT04697992
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
A study testing vitamin c 20% and Tranexamic acid 5mg/ml in people with Periorbital Hyperpigmentation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periorbital Hyperpigmentation
- What is being tested?
- vitamin c 20% and Tranexamic acid 5mg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both genders.
- age ≥ 18 years.
- pigmentary, vascular and mixed types of dark halos
Who cannot join
- pregnancy and lactation
- patients who received treatment in the past 3 months
- patients with active dermatologic diseases or history of atopic dermatitis.
- history of allergy to tranexamic acid or vitamin c
- history of keloid or hypertrophic scars
- pure structural type of dark halos, pigmentary demarcation lines
Trial locations and contacts
1 site in 1 country.
About this study
Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (VAS) and dermatology life quality index (DLQI).
Read the detailed description
Sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (VAS) and DLQI were done at week 0. Group A one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group B one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). A total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. At week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, VAS, DLQI, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. The study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin C.
- Conditions
- Periorbital Hyperpigmentation
- Being tested
- vitamin c 20%, Tranexamic acid 5mg/ml
- Keywords
- Periorbital hyperpigmentation, Vitamin C, Tranexamic acid, Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin c 20%Drug
Also called vitamin c 20% global cosmetic solutions
one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).
Tranexamic acid 5mg/mlDrug
Also called kapron 500mg/ 5ml
one eye was treated with tranexamin acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling)
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling). Receives: Drug: vitamin c 20% |
| group B | Experimental | one eye was treated with tranexamic acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling). Receives: Drug: Tranexamic acid 5mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
this is evaluated using dermoscopy (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=>75% improvement)
Measured: 10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
clinical improvement by two blinded investigators (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=>75% improvement)
Measured: 10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
clinical improvement by physician (grade from 0 to 4 according to sheth et al.,2014 where 0 no halos and 4 most severe)
Measured: 10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
dermatology life quality index (score from 0 to 30 the higher the worst)
Measured: 10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
patient visual analogue score (score from 0 to 10 the higher the worst)
Measured: 10 weeks (patients are assissed 1 month after the last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Nov 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- clinical trial, patients were divided into two groups, 30 each.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohsen, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697992
- Sponsor's protocol ID
- cosmo26
- Status last verified
- Jan 2021
- First submitted
- 26 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: im looking forward sharing the data but i have no plan yet
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
- ClinicalTrials.gov ID
- NCT04697992
- Acronym / sponsor ID
- cosmo26
- Conditions
- Periorbital Hyperpigmentation
- Keywords
- Periorbital hyperpigmentation, Vitamin C, Tranexamic acid, Microneedling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (VAS) and dermatology life quality index (DLQI).
Detailed description
Sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (VAS) and DLQI were done at week 0. Group A one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group B one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). A total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. At week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, VAS, DLQI, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. The study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin C.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- clinical trial, patients were divided into two groups, 30 each.
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: vitamin c 20%one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling). |
| group B | Experimental | Drug: Tranexamic acid 5mg/mlone eye was treated with tranexamic acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both genders.
- age ≥ 18 years.
- pigmentary, vascular and mixed types of dark halos
Key exclusion criteria (6 listed)
- pregnancy and lactation
- patients who received treatment in the past 3 months
- patients with active dermatologic diseases or history of atopic dermatitis.
- history of allergy to tranexamic acid or vitamin c
- history of keloid or hypertrophic scars
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin c 20%Also: vitamin c 20% global cosmetic solutionsone eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling). | Drug | group A |
| Tranexamic acid 5mg/mlAlso: kapron 500mg/ 5mlone eye was treated with tranexamin acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling) | Drug | group B |
Primary outcome
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Time frame: 10 weeks (patients are assissed 1 month after the last session)
this is evaluated using dermoscopy (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=>75% improvement)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Time frame: 10 weeks (patients are assissed 1 month after the last session)
clinical improvement by two blinded investigators (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=>75% improvement)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Time frame: 10 weeks (patients are assissed 1 month after the last session)
clinical improvement by physician (grade from 0 to 4 according to sheth et al.,2014 where 0 no halos and 4 most severe)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Time frame: 10 weeks (patients are assissed 1 month after the last session)
dermatology life quality index (score from 0 to 30 the higher the worst)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Time frame: 10 weeks (patients are assissed 1 month after the last session)
patient visual analogue score (score from 0 to 10 the higher the worst)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No. im looking forward sharing the data but i have no plan yet
Related trials for Periorbital Hyperpigmentation
Active, not recruiting
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
Melasma, Rosacea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin c 20% and Tranexamic acid 5mg/ml in people with Periorbital Hyperpigmentation, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation (time frame: 10 weeks (patients are assissed 1 month after the last session)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.