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Trial record 36 of 142 for:    acne AND erythema

Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

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ClinicalTrials.gov Identifier: NCT03765021
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Maha Fathy Elmasry, Cairo University

Brief Summary:
comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation

Condition or disease Intervention/treatment Phase
Post Inflammatory Hyperpigmentation Drug: Tranexamic Acid Device: Fractional CO2 laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Official Title: Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Tranexamic acid injection (Kapron)
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
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.
Other Name: Kapron

Active Comparator: Fractional CO2 laser resurfacing
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
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.




Primary Outcome Measures :
  1. Measurement of melanin index to assess change of post-acne hyperpigmentation [ Time Frame: 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

  2. Measurement of erythema index to assess change of post-acne hyperpigmentation [ Time Frame: 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

  3. Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation [ Time Frame: 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).

  4. Patient satisfaction score to assess change of post-acne hyperpigmentation [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Maha Fathy Elmasry, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03765021     History of Changes
Other Study ID Numbers: Dermatology 9
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants