Therapeutic EfficacyPhase 1NCT03885895
Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.
A Phase 1 study testing Tranexamic Acid Injectable Product and Q switched KTP (532nm) in people with Therapeutic Efficacy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Therapeutic Efficacy
- What is being tested?
- Tranexamic Acid Injectable Product and Q switched KTP (532nm)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2019to Dec 2019
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age group > 18years old.
Who cannot join
- Pregnant and lactating females.
- Keloid and scarring tendancy
- Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
- Oral Isotretinoin 6 months prior to the study.
- Active herpetic lesions.
- Any concurrent active skin disease within the treated area.
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- Photosensitive skin conditions such as systemic lupus erythematous.
- History of delayed wound healing.
- Bleeding diathesis.
- Medical conditions such as autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Ainy university hospital
Cairo, 11956
Samar Tuqan, 01003133495 ext. 02, samartuqan@gmail.com
About this study
Official title: Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)
Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).
Read the detailed description
One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.
The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.
The sessions of TXA will be every 2 weeks for 2 months.
Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.
Follow up after treatment monthly for 2 month.
- Conditions
- Therapeutic Efficacy
- Being tested
- Tranexamic Acid Injectable Product, Q switched KTP (532nm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injectable ProductDrug
Ampoules used for intradermal injection
Q switched KTP (532nm)Device
LASER
| Study group | Role | What they receive |
|---|---|---|
| Participants with freckles (one side of the face) | Active comparator | one randomized side of the face will be treated by Intradermal Tranexamic acid Receives: Drug: Tranexamic Acid Injectable Product |
| Participants with freckles (other side of the face) | Active comparator | other side will be treated by Q switched KTP laser Receives: Device: Q switched KTP (532nm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation and severity index by clinical evaluation
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Measured: 6 months to 1 year
Melanin Index change by spectrophotometer
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Measured: 6 months to 1 year
Blinded observers' evaluation
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Measured: 6 months to 1 year
Patient satisfaction rate
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start15 Jan 2019
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EfficacyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885895
- Sponsor's protocol ID
- EgyFreckles
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)
- ClinicalTrials.gov ID
- NCT03885895
- Acronym / sponsor ID
- EgyFreckles
- Conditions
- Therapeutic Efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Mar 2019 (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.
Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).
Detailed description
One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.
The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.
The sessions of TXA will be every 2 weeks for 2 months.
Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.
Follow up after treatment monthly for 2 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with freckles (one side of the face) | Active comparator | Drug: Tranexamic Acid Injectable Productone randomized side of the face will be treated by Intradermal Tranexamic acid |
| Participants with freckles (other side of the face) | Active comparator | Device: Q switched KTP (532nm)other side will be treated by Q switched KTP laser |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Both genders
- Age group > 18years old.
Key exclusion criteria (10 listed)
- Pregnant and lactating females.
- Keloid and scarring tendancy
- Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
- Oral Isotretinoin 6 months prior to the study.
- Active herpetic lesions.
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 |
|---|---|---|
| Tranexamic Acid Injectable ProductAmpoules used for intradermal injection | Drug | Participants with freckles (one side of the face) |
| Q switched KTP (532nm)LASER | Device | Participants with freckles (other side of the face) |
Primary outcome
Pigmentation and severity index by clinical evaluation
Time frame: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Melanin Index change by spectrophotometer
Time frame: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Blinded observers' evaluation
Time frame: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Patient satisfaction rate
Time frame: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tranexamic Acid Injectable Product and Q switched KTP (532nm) in people with Therapeutic Efficacy, 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Tuqan (01003133495 ext. 02, samartuqan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pigmentation and severity index by clinical evaluation (time frame: 6 months to 1 year). The study lists 4 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 22 Mar 2019.