Post Inflammatory Hyperpigmentation Clinical Trial
Official title:
Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients
Verified date | November 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months | |
Primary | 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 | 3 months | |
Primary | 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). | 3 months | |
Primary | 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 | 3 months |
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