Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris

• ClinicalTrials.gov Identifier: NCT01461655
• Recruitment Status: Completed
• First Posted: October 28, 2011
• Results First Posted: December 4, 2013
• Last Update Posted: February 15, 2017
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

Brief Summary:

The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: marketed topical retinoid; Drug: marketed topical NSAID; Drug: vehicle gel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Exploratory Study Evaluating the Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris, Using a Split-Face Model
• Study Start Date: November 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Topical retinoid - Placebo	Drug: vehicle gel; once daily application, 4 weeks; Drug: marketed topical retinoid; once daily application, 4 weeks
Active Comparator: Topical retinoid-NSAID	Drug: marketed topical retinoid; once daily application, 4 weeks; Drug: marketed topical NSAID; once daily application, 4 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage Change in Inflammatory Lesions From Baseline to End of Treatment [ Time Frame: Baseline to End of treatment (4 weeks) ]
   Percentage change in inflammatory lesions count from baseline to the end of treatment

Secondary Outcome Measures :

1. Non-inflammatory Lesions Count [ Time Frame: Baseline to End of treatment (4 weeks) ]
   Percentage change in non-inflammatory lesions count from baseline to the end of treatment
2. Total Lesions Count [ Time Frame: Baseline to End of treatment (4 weeks) ]
   Percentage change in total lesions count from baseline to the end of treatment
3. Percentage Change in Total Lesions Count [ Time Frame: Baseline to Day 8 ]
   Percentage change in total leasions count from baseline to day 8
4. Percentage Change in Total Lesions Count [ Time Frame: Baseline to Day 15 ]
   Percentage change in total lesions count from baseline to day 15
5. Percentage Change in Total Lesions Count [ Time Frame: Baseline to Day 22 ]
   Percentage change in total lesions count from baseline to day 22
6. Investigator Global Assessment (IGA) of Disease Severity [ Time Frame: Baseline to End of treatment (4 weeks) ]

   The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).

   The outcome was the proportion of "success" (improvement of two grades of the IGA) from baseline to the end of treatment. "Success" is defined as improvement of two grades from the baseline assessment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subjects having understood and signed an informed consent form
• Male or female subjects who are 18 to 35 years (both included) of age presenting acne vulgaris of the face.
• A minimum of 10 inflammatory lesions (papules and pustules) on the entire face, and a minimum of 20 non-inflammatory lesions (open comedones and closed comedones) on the entire face.
• Disease severity grade as mild or moderate according to the investigator's global assessment (grade 2 or grade 3)

Exclusion Criteria:

• Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
• Subjects with any acne cysts or more than one nodule per hemiface.
• Subjects with acne conglobata, acne fulminans, secondary acne (e.g. chloracne, drug-induced acne), or any acne requiring systemic treatment.
• Subjects with a dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin type V or VI on Fitzpatrick scale.
• Subjects with other facial skin disorders that may interfere with study assessments.
• Subjects who will use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) on the face for the duration of the study.
• Subjects with a history of actinic keratosis on the face or skin cancer.
• Use of hormonal oral contraceptives for acne control for less than 6 months prior to the randomisation.
• Subjects using one of the following systemic medication within 4 weeks before the randomisation and during the study, which could have an effect on the trial disease.
• systemic corticosteroids,
• anti-acne drugs,
• oral retinoids
• any immunosuppressive drugs.
• Subjects using systemic NSAIDs (including aspirin) within 1 week before the randomisation and during the study.
• Subjects using paracetamol within 1 week before the randomisation. Paracetamol will be allowed during the study with a maximum dose of 1g twice daily and for a maximum of 3 consecutive days
• Subjects using one of the following topical medication within 2 weeks before the randomisation and during the study, which could have an effect on the trial disease:
• anti-inflammatory drugs (e.g. topical corticosteroids, NSAIDs),
• anti-acne drugs,
• topical retinoids,
• topical antibacterial agents
• any topical immunosuppressive drugs.
• Subjects with known or suspected hypersensitivity to component(s) of the investigational products or other nonsteroidal anti- inflammatory drug NSAIDs (e.g., aspirin, diclofenac, ibuprofen, ketoprofen).
• Subjects with presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting).
• Subjects with known presence of active peptic ulcer.
• Subjects with history (during the last 10 years) or known presence of asthma.
• Subjects with history (during the last 5 years) or known presence of rhinitis or urticaria

Contacts and Locations

Locations

France

CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, France, 06202

Sponsors and Collaborators

LEO Pharma

Investigators

• Principal Investigator: Catherine Mrs Queille-Roussel, MD; Centre de Pharmacologie Clinique Applique a la Dermatologie

More Information

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01461655
• Other Study ID Numbers: LP0045-01; 2011-000244-24 ( EudraCT Number )
• First Posted: October 28, 2011
• Results First Posted: December 4, 2013
• Last Update Posted: February 15, 2017
• Last Verified: December 2016

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases