Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 05/31/2018 |
| Enviado pela primeira vez: | 03/05/2017 |
| Inscrição estimada enviada: | 03/08/2017 |
| Postado pela primeira vez: | 03/09/2017 |
| Última atualização enviada: | 06/04/2018 |
| Última atualização postada: | 06/06/2018 |
| Data real de início do estudo: | 03/26/2017 |
| Data Estimada de Conclusão Primária: | 01/30/2019 |
| Data Estimada de Conclusão do Estudo: | 03/30/2019 |
Condição ou doença
Intervenção / tratamento
Combination Product: PFD+M-DDO
Combination Product: A+PBO
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: PFD+M-DDO Pirfenidone with M-DDO Active ingredients: Pirfenidone 10% with modified oxide diallyl disulfide (M-DDO) 0.016% Dosage form: gel. Dosage: standard finger tip unit (0.5g for an area of 100 to 120 square centimeters).
Frequency an duration: topically applied every 12 hours for 6 months. | Combination Product: PFD+M-DDO Participants with moderate and severe acne will be treated two times a day on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Zaxcell (Pirfenidone with M-DDO) in form of a gel. Patients have to wait 20 min without cover those sites. |
| Active Comparator: A+PBO Adapalene with benzoyl peroxide Active ingredients: 0.1% Adapalene with 2.5% benzoyl peroxide. Dosage form: gel. Dosage: standard finger tip unit (0.5g for an area of 100 to 120 square centimeters).
Frequency and duration: topically applied every 12 hours for 6 month | Combination Product: A+PBO Participants with moderate and severe acne will be treated once a day (at night) on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Effezel (Adapalene with benzoyl peroxide) in form of a gel. Patients have to wait 20 min without cover those sites |
Critério de eleição
| Idades qualificadas para estudar | 12 Years Para 12 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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. |
Resultado
Medidas de Resultado Primário
1. Assessing change of lesions with IGA scale (Investigators' Global Assessment) [1, 2, 3, 4, 5 and 6 months]
Medidas de Resultado Secundário
1. Histopathological modification on the inflammatory lesions and improvement in the scarring process [1 and 3 months]
2. 2. Expression levels of key molecules involved in acne inflammation and scar remodeling [1 and 3 months]
3. Photonumeric scale [1, 3 and 6 months]
