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Trial record 29 of 233 for:    acne AND Percent

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

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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:
Information provided by (Responsible Party):
LEO Pharma

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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




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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461655


Locations
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France
CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Nice, France, 06202
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Catherine Mrs Queille-Roussel, MD Centre de Pharmacologie Clinique Applique a la Dermatologie

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

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases