|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
18 July 2023 |
|
Main ID: |
NCT03076320 |
|
Date of registration:
|
06/03/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne
|
|
Scientific title:
|
Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne |
|
Date of first enrolment:
|
March 27, 2017 |
|
Target sample size:
|
82 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03076320 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Subjects of both genders male or female of any race, 12 to 25 years or age.
- Subjects with a clinical diagnosis of acne vulgaris with facial and back involvement.
- Subjects with a minimum of 20 but not more tan 150 inflammatory lesions on the face
(including the nose)
- Subjects with a minimum of 30 but no more 200 non-inflammatory lesions on the face
(including the nose)
- Subjects with minimum of 20 but no more than 250 inflammatory lesions on the superior
back area.
- Investigator's Global Assessment (IGA) score of 3 or 4, corresponding to moderate and
severe acne. Subjects with no more than two active nodules at baseline.
- Subjects that agree to fill a clinical history, access to physical exploration and
biochemical analysis samples, biopsy of the back and photo-documentation of affected
areas on the face and back.
- Consent to participate, verified by signing an approved written Informed Consent Form,
or for subjects under age 18, an assent form in conjunction with a signed Informed
Consent Form from a parent/guardian.
- Patients willing to sign a compliance letter to apply treatment as indicated by the
principal investigator.
- Willingness and capacity of protocol compliance (for subjects under 18 years of age,
parent/guardian must be wiling and able to comply with study requirements).
- Subjects willing to share personal information and data as verified by signing a
written authorization, as applicable
Exclusion Criteria:
- Acne conglobata, acne fulminans, secondary acne.
- Subjects with another chronic inflammatory disease of the skin.
- Subjects with severe acne requiring isotretinoin therapy or other dermatological
conditions, which might, in the opinion of the Investigator, interfere with the study
evaluation or pose a risk to patient safety during the study.
- Pregnancy, nursing or planning a pregnancy.
- Men with facial hair that would interfere with the assessments.
- Subjects with background history of keloid scarring.
- Known sensitivities to the study preparations.
- Participation in another investigational drug or device research study within 30 day
of enrollment.
- Specified washout period to baselines for systemic or topical medications.
- Subjects refusing to the biopsy of the back and photographic procedures.
Age minimum:
12 Years
Age maximum:
25 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
|
|
Intervention(s)
|
|
Combination Product: A+PBO
|
|
Combination Product: PDF+M-DDO
|
|
Primary Outcome(s)
|
|
Assessing change of lesions with IGA scale (Investigators' Global Assessment)
[Time Frame: 1, 2, 3, 4, 5 and 6 months]
|
|
Secondary Outcome(s)
|
|
Photonumeric scale
[Time Frame: 1, 3 and 6 months]
|
|
Histopathological modification on the inflammatory lesions and improvement in the scarring process
[Time Frame: 1 and 3 months]
|
|
2. Expression levels of key molecules involved in acne inflammation and scar remodeling
[Time Frame: 1 and 3 months]
|
|
Secondary ID(s)
|
|
267/15
|
|
IBMMTG 15-02
|
|
008/16
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|