Clinical Trial: Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne

Brief Summary:

Acne vulgaris is a complex skin disorder involving multiple abnormalities of the pilosebaceous unit. Acne is the most common skin disease during puberty and worsens throughout adolescence. However, epidemiological studies suggest that acne can arise at any age, most frequently affecting individuals between puberty and 30 years of age, with 79%-95% of subjects aged between 16 years and 18 years and 80% of subjects between puberty and 30 years of age. Acne is considered the main reason for consultation with the dermatologist in institutional and private clinical practice.

Clinical features include seborrhoea, non-inflammatory lesions, inflammatory lesions and various degrees of scarring. There are many classifications of acne and scarring severity. Moderate to severe acne is about 15-20%.

Facial acne scarring affects both sexes equally and occurs to some degree in up to 95% of cases. There is a significant correlation between the initial acne grade and the overall severity of scarring at all sites and in both sexes. This would suggest that treatment aimed at reducing the severity of acne might reduce the incidence of scarring. Both superficial inflammatory acne lesions as well as deep nodular lesions seem capable of producing scars.

Conventional therapies recommended for the treatment of acne vulgaris include retinoids, benzoyl peroxide (BPO), antibiotics, and hormonal therapy. Combination therapy using agents with complementary mechanisms provides the opportunity to target multiple pathogenetic causes of acne vulgaris.

The combination in gel with 0.1% adapalene and 2.5% BPO is a once-daily treatment of acne vulgaris. In several double- blind, randomized controlled trials (RCTs), the Adapalene-BPO (A-BPO) combination therapy a

Detailed Summary: Participants will be randomized using a random number table to distribute in the control (Effezel) and the experimental group (Pirfenidone+M-DDO). Before screening, participants will undergo an informed consent process and they will sign an institutional review board-approved informed consent form. The study will be conducted in accordance with Good Clinical Practices and the principles that have their origins in the Declaration of Helsinki (revised Seoul, Korea, 2008). Potential subjects with acne scars will be selected from the investigators practices and solicited from advertisements. To be included, subjects must have met the inclusion criteria. Demographics data and medical history will be registered on a monthly basis. Before treatment, all subjects with inflammation and scars will be evaluated in the face and back area using the Investigator´s Global Assessment scale (IGA scale) and all the lesions will be counted. The face and back area affected will be mapped and photographed. Participants in the experimental group will receive topical Zaxcell (Pirfenidone 10% +M-DDO gel) two times a day on the face and superior back and patients in control group will receive Effezel (Adapalene 0.1%+Benzoyl peroxide 2.5%) once a day. Both groups will apply the topical treatment in acne on the face and superior back area for six months previous cleansing of the area with neutral soap. Two biopsies of skin will be taken at the beginning, at month one and month 3 from the back area where the treatment will be applied. After this time, only clinical evaluations and photographs will be performed. Participants will be evaluated at every month until 6 months after their last application.
Sponsor: University of Guadalajara

Current Primary Outcome: Assessing change of lesions with IGA scale (Investigators' Global Assessment) [ Time Frame: 1, 2, 3, 4, 5 and 6 months ]

Number or lesions


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Histopathological modification on the inflammatory lesions and improvement in the scarring process [ Time Frame: 1 and 3 months ]
    Biopsy from the upper back area
  • 2. Expression levels of key molecules involved in acne inflammation and scar remodeling [ Time Frame: 1 and 3 months ]
    Biopsy from the upper back area
  • Photonumeric scale [ Time Frame: 1, 3 and 6 months ]
    Photographs of the treated area analyzed by three-dimensional reconstruction software


Original Secondary Outcome: Same as current

Information By: University of Guadalajara

Dates:
Date Received: March 6, 2017
Date Started: March 27, 2017
Date Completion: January 31, 2018
Last Updated: March 27, 2017
Last Verified: March 2017