Comparative Study of Photodynamic Therapy with Riboflavin-Tryptophan Gel and 13% 5-Aminolevulinic Acid in the Treatment of Mild to Moderate Acne Vulgaris

Not Applicable

Completed

• Conditions: Mild to moderate acne vulgaris patients; Acne vulgaris, photodynamic therapy, photosensitizer, 5- aminolevulinic acid, riboflavin, tryptophan

• Registration Number: TCTR20190907005
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-07-31
• Study Start: 2019-09-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

-Patient aged 18-50 years old
-Mild to moderate acne vulgaris patients

Exclusion Criteria

-Use of any topical acne treatment or systemic antibiotics within 2 weeks before study initiation.
-Use of a systemic retinoid within 9 months before study initiation.
-Use of a systemic steroid within 9 months before study
initiation.
-Using medication that may exacerbate or alleviate acne such as halogens (iodides,chlorides,bromides, halothane), antiepileptics (carbamazepine, phenytoin, phenobarbital), antituberculous (ethionamide, isoniazid, rifampicin), antidepressants (lithium, amoxapine), Ciclosporin,B vitamins (B6, B12, cyanocobalamin).
-Recent use of photosensitizing drugs such as tetracyclines, fluoroquinolones, sulfonamides, ibuprofen, ketoprofen, naproxen, furosemide and statins within 6 weeks before study initiation.
-History of photosensitivity.
-History of keloid.
-Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea.
-Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases.
-Presence of any change in the use of oral contraceptive pills or anti-inflammatory drugs within 3 months before study initiation.
-Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Acne Assessment Score (GAAS) week 0,1,2,3,5, and 7 evaluated by dermatologists ,Fluorescence photography week 0,1,2,3,5, and 7 wood’s lamp ,Adverse Effects week 0,1,2,3,5, and 7 clinical evaluation of erythema, edema, hyperpigmentation, hemorrhage, vesiculation, and exfoliation,Sebum output week 0,1,2,3,5, and 7 Sebumeter® ,Acne lesion counts week 0,1,2,3,5, and 7 evaluated by dermatologists ,Patients’ satisfaction week 0,1,2,3,5, and 7 patients own observation

Secondary Outcome Measures

Name	Time	Method
wrinkles, texture, scars, skin color, redness and pigmentation week 0,1,2,3,5, and 7 Antera3D