Therapeutic Efficacy
Conditions
Brief 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).
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.
Interventions
Ampoules used for intradermal injection
DEVICEQ switched KTP (532nm)
LASER
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Both genders * Age group \> 18years old.
Exclusion criteria
* 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. * Photosensitive skin conditions such as systemic lupus erythematous. * History of delayed wound healing. * Bleeding diathesis. * Medical conditions such as autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinded observers' evaluation | 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 |
| Pigmentation and severity index by clinical evaluation | 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 | 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 | 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 |
Countries
Egypt
Contacts
Primary ContactSamar Tuqan
Outcome results
None listed