Clinical Trial Phase III to Assess the Non-inferiority of Dalap Duo® Product Compared to Epiduo® in the Treatment of Acne Vulgaris

NCT02716090 | Withdrawn Phase 3

• 1 other identifier: ACH-DLP-03(01/13)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the non-inferiority of the product Dalap Duo® compared to Epiduo® medicine to treat acne. Half of the participants will receive Dalap Duo®, while the other half will receive Epiduo®.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Reduction of total acne lesion

  Percentage reduction of total acne lesion on the face other than the region of the nose by manual counting performed by the investigator.

  84 days

Secondary Outcomes (4)

• Reduction of number of inflammatory lesions

  07, 14, 28, 56 and 84 days

• Reduction in non-inflammatory lesions

  07, 14, 28, 56 and 84 days

• Improvement of acne through Global assessment of investigator

  07, 14, 28, 56 and 84 days

• Efficiency perceived by participant

  84 days

Study Arms (2)

Dalap Duo®

EXPERIMENTAL

0.1% of adapalene and 2.5% and benzoyl peroxide gel cream. Apply the product on the areas affected by acne once a day in the evening for 84 days.

Drug: Adapalene and Benzoyl peroxide Dalap Duo®

Epiduo®

ACTIVE COMPARATOR

0.1% of adapalene and 2.5% and benzoyl peroxide gel. Apply the product on the areas affected by acne once a day in the evening for 84 days.

Drug: Adapalene and Benzoyl peroxide Epiduo®

Interventions

Adapalene and Benzoyl peroxide Dalap Duo® DRUG

Dalap Duo®

Adapalene and Benzoyl peroxide Epiduo® DRUG

Epiduo®

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• female or male Participant
• Age older than or equal to 12 years;
• non-inflammatory facial lesions, except in the nose region (comedo closed and open comedo - degree 1) and 20 to 50 inflammatory facial lesions, except in the nose region (papule and pustule - degree 2);
• Ability to understand and consent to participate in this clinical study, expressed by signing the consent form;
• Search Participant willing to not use, for the entire period of the study drugs, cosmetics and / or treatments for acne, according to the investigator, that may influence the study results, such as, but not limited to, treatment with oral and topical retinoids.

You may not qualify if:

• Any finding of clinical observation (clinical assessment / physical) that is interpreted by the investigator as a risk to safety or which may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
• Any laboratory examination found that the investigator consider as safety risk or that may interfere with the effectiveness of the treatment and research of the participants in the clinical trial;
• Known hypersensitivity to the drug components used during the study;
• female participants with a history of polycystic ovary syndrome (Stein-Leventhal syndrome);
• Women with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding;
• Women in the reproductive age who do not agree to use acceptable contraception \[oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation\]; other than surgically sterile (bilateral oophorectomy or hysterectomy) or sexual abstinence or who have not yet initiated sexual activity;
• Person who has participated in clinical trial protocols in the last twelve (12) months, unless the investigator considers that there may be direct benefit to him/her;
• Participant who has some kinship to the second degree or bond with employees or employees of Sponsor and Research Center;
• Women in menopausal or postmenopausal period;
• Any feature in the test areas (face) that according to the investigator may influence the results, for example, BUT NOT LIMITED TO moles, tattoos, scars, irritated skin, scratches, cuts and excess hair;
• Participants diagnosed with Diabetes Mellitus after evaluation of the result of the test, defined as the presence of the classic symptoms of diabetes mellitus assessed the visit V-1 associated with the higher level of casual plasma glucose or equal to 200 mg / dL according to the American Diabetes Association (DIABETES CARE, VOLUME 33, SUPPLEMENT 1, JANUARY 2010);
• Presence of dermatoses related to diabetes mellitus (plantar ulcer, necrobiosis lipoid, annular granuloma, dermatophytosis, deep mycoses, bacterial infections, opportunistic infections);
• immune impairment;
• Dermatological diseases in the test area (face): vitiligo, psoriasis, atopic dermatitis;
• Participant using topical treatment for acne in the 15 days preceding the screening visit (V-1) or oral treatment for acne in the 30 days preceding the screening visit (V-1) or plan to use during the study period;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: March 23, 2016
• Primary Completion: November 1, 2015
• Last Updated: February 15, 2017

Record last verified: 2017-02