NCT05666765

Brief Summary

This study aims to compare the effects of isotretinoin and silymarin or both in treatment of acne and their effects on the level of IGF-1, SAA1 and malondialdehyde (MDA) in acne patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

December 8, 2022

Last Update Submit

December 18, 2022

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Global Acne Grading Classification

    Global Acne Grading System (GAGS) Each is derived by multiplying the factors-2 for forehead, 2 for each check, 1 for nose, 1 for chin, 3 for both chest and back by the most heavily weighted lesion within each region (1 for ≥ one comedone, 2 for ≥ one papule,3 for ≥ one pustule, and 4 for ≥ one nodule).

    3 months

Secondary Outcomes (5)

  • Liver function tests

    3 months

  • Lipid profile

    3 months

  • Insulin growth factor -1

    3 months

  • serum amyloid A1

    3 months

  • Malondialdehyde

    3 months

Study Arms (3)

acne vulgaris patients group 1

EXPERIMENTAL

acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)

Drug: Isotretinoin ,silymarin

acne vulgaris patients group 2

EXPERIMENTAL

acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)

Drug: Isotretinoin ,silymarin

acne vulgaris patients group 3

EXPERIMENTAL

acne patients will be rondomly assigned to 1 of the 3 interventions (isotretinoin, silymarin, or both)

Drug: Isotretinoin ,silymarin

Interventions

Isotretinoin ,silymarinDRUG

20mg/day isotretinoin for 3 months. 140 mg/day silymarin for 3 months. 20mg/day isotretinoin and 140mg/day silymarin for 3 months.

acne vulgaris patients group 1acne vulgaris patients group 2acne vulgaris patients group 3

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 16 years or more. Patient with moderate or severe acne. Not receiving acne treatment in the last month.

You may not qualify if:

  • Pregnancy or lactation. Patients with known hypersensitivity to isotretinoin or silymarin. Patients with depression, liver diseases or high cholesterol. Patients with acromegaly. Patients with chronic inflammatory, infective or neoplastic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Related Publications (2)

  • Hazarika N. Acne vulgaris: new evidence in pathogenesis and future modalities of treatment. J Dermatolog Treat. 2021 May;32(3):277-285. doi: 10.1080/09546634.2019.1654075. Epub 2019 Aug 29.

    PMID: 31393195BACKGROUND

  • Shie Morteza M, Hayati Z, Namazi N, Abdollahimajd F. Efficacy and safety of oral silymarin in comparison with oral doxycycline and their combination therapy in the treatment of acne vulgaris. Dermatol Ther. 2019 Nov;32(6):e13095. doi: 10.1111/dth.13095. Epub 2019 Oct 21.

    PMID: 31579978BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Ghada F Hassan, A.professor

    Tanta University

    STUDY CHAIR

  • Dalia R Elafify, Doctor

    Tanta University

    STUDY CHAIR

Central Study Contacts

Ghada M Tantawy, Doctor

CONTACT

00201144062267Ghadamtantawy@gmail.com

Sahar M El-hagger, Professor

CONTACT

0020403336007

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 28, 2022

Study Start

January 1, 2023

Primary Completion

November 1, 2023

Study Completion

January 1, 2024

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)