An interventional study of Tranexamic Acid and Fractional CO2 laser in Post Inflammatory Hyperpigmentation, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation
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.
102 studies on the registry are indexed under Hyperpigmentation; 20 are open to participants now.
This study's planned enrollment of 25 is below the median of 38 across 89 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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.
Drug: Tranexamic Acid
The other side of the face will be randomly assigned to do 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.
Device: Fractional CO2 laser
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.
Also known as: Kapron
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.
Measurement of melanin index to assess change of post-acne hyperpigmentation
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
Time frame: 3 months
Measurement of erythema index to assess change of post-acne hyperpigmentation
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
Time frame: 3 months
Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation
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).
Time frame: 3 months
Patient satisfaction score to assess change of post-acne hyperpigmentation
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
Time frame: 3 months
No study locations are listed for this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Cairo University