Post Inflammatory Hyperpigmentation
Conditions
Brief summary
comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation
Detailed description
Randomized controlled split-face study. One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months. The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
Interventions
DRUGTranexamic Acid
One side of the face will be assigned to TXA intradermal microinjection 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 hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.
DEVICEFractional CO2 laser
The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Method of randomization: using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Egyptians of both sexes. * Age \> 18. * Patients who can avoid sun exposure one week after sessions. * Patients who stopped taking systemic isotretinoin for more than six months.
Exclusion criteria
* Pregnancy and lactation. * Concomitant use of anticoagulants. * Bleeding disorders. * Personal or family history of DVT or thromboembolic events. * Scarring and keloid tendency. * Active skin infection, active HSV. * History of photosensitivity or photosensitizing medication. * Occupational sun exposure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of melanin index to assess change of post-acne hyperpigmentation | 3 months | the melanin index (MI) average is 1.10 +/-0.29 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation |
| Measurement of erythema index to assess change of post-acne hyperpigmentation | 3 months | the erythema index (EI) average is 1.29 +/- 0.38 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of erythema |
| Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation | 3 months | the post-acne hyperpigmentation index (PAHPI) ranges from 6-22 with higher values showing worse outcome. It is a summation of three scores (Postinflammatory hyperpigmentation(PIH) lesion size, median lesion intensity compared with surrounding skin and the number of PIH lesions). |
| Patient satisfaction score to assess change of post-acne hyperpigmentation | 3 months | It is a score ranging from 1-4 with improvement 0-25%=1, 26-50%= 2, 51-75%=3 and more than 75%=4 so higher values of patient satisfaction score showing better outcome |
Outcome results
None listed