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

NCT01461655 | Completed Phase 2 Results

• 2 other identifiers: LP0045-012011-000244-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Inflammatory Lesions From Baseline to End of Treatment

  Percentage change in inflammatory lesions count from baseline to the end of treatment

  Baseline to End of treatment (4 weeks)

Secondary Outcomes (6)

• Non-inflammatory Lesions Count

  Baseline to End of treatment (4 weeks)

• Total Lesions Count

  Baseline to End of treatment (4 weeks)

• Percentage Change in Total Lesions Count

  Baseline to Day 8

• Percentage Change in Total Lesions Count

  Baseline to Day 15

• Percentage Change in Total Lesions Count

  Baseline to Day 22

Study Arms (2)

Topical retinoid - Placebo

PLACEBO COMPARATOR

Drug: vehicle gel; Drug: marketed topical retinoid

Topical retinoid-NSAID

ACTIVE COMPARATOR

Drug: marketed topical retinoid; Drug: marketed topical NSAID

Interventions

marketed topical retinoid DRUG

once daily application, 4 weeks

Topical retinoid-NSAID

marketed topical NSAID DRUG

once daily application, 4 weeks

Topical retinoid-NSAID

vehicle gel DRUG

once daily application, 4 weeks

Topical retinoid - Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, 06202, France

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Catherine Mrs Queille-Roussel, MD

  Centre de Pharmacologie Clinique Applique a la Dermatologie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 28, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 10, 2025
• Results First Posted: December 4, 2013

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)