Trial Outcomes & Findings for Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris (NCT NCT01461655)

NCT ID: NCT01461655

Last Updated: 2025-03-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline to End of treatment (4 weeks)
• Results posted on: 2025-03-10

Participant Flow

Start date: 21-NOV-2011 (FSFV - first subject first visit) Completion date: 26-APR-2012 (LSLV - last subject last visit)

Participant milestones

Measure	Topical Retinoid - Placebo, Topical Retinoid - NSAID Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris. The randomised subjects received the following products: * NSAID 5% gel , in the morning on the appropriate hemiface. * Topical retinoid 0.1% gel, in the evening on the entire face. * Vehicle gel, in the morning on the appropriate hemiface.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Topical Retinoid - Placebo, Topical Retinoid - NSAID n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.7 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment France	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to End of treatment (4 weeks)

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

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Percentage Change in Inflammatory Lesions From Baseline to End of Treatment	-20.3 percentage of change Standard Deviation 45.3	-29.4 percentage of change Standard Deviation 37.0

SECONDARY outcome

Timeframe: Baseline to End of treatment (4 weeks)

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

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Non-inflammatory Lesions Count	-41.4 percentage of change Standard Deviation 31.2	-43.1 percentage of change Standard Deviation 37.6

SECONDARY outcome

Timeframe: Baseline to End of treatment (4 weeks)

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

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Total Lesions Count	-35.4 percentage of change Standard Deviation 24.0	-39.9 percentage of change Standard Deviation 27.0

SECONDARY outcome

Timeframe: Baseline to Day 8

Percentage change in total leasions count from baseline to day 8

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Percentage Change in Total Lesions Count	-20.4 percentage of change Standard Deviation 24.1	-21.1 percentage of change Standard Deviation 28.6

SECONDARY outcome

Timeframe: Baseline to Day 15

Percentage change in total lesions count from baseline to day 15

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Percentage Change in Total Lesions Count	-24.9 percentage of change Standard Deviation 24.3	-22.2 percentage of change Standard Deviation 29.0

SECONDARY outcome

Timeframe: Baseline to Day 22

Percentage change in total lesions count from baseline to day 22

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Percentage Change in Total Lesions Count	-35.7 percentage of change Standard Deviation 21.8	-32.5 percentage of change Standard Deviation 30.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Topical Retinoid - Placebo n=40 Participants marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks	Topical Retinoid-NSAID n=40 Participants marketed topical NSAID : once daily application, 4 weeks marketed topical retinoid : once daily application, 4 weeks
Investigator Global Assessment (IGA) of Disease Severity	0 participants	1 participants

Adverse Events

Topical Retinoid - Placebo, Topical Retinoid - NSAID

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Topical Retinoid - Placebo, Topical Retinoid - NSAID n=40 participants at risk
Eye disorders Eyelid oedema	5.0% 2/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Infections and infestations Nasopharyngitis	12.5% 5/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Musculoskeletal and connective tissue disorders Back pain	7.5% 3/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Nervous system disorders Headache	22.5% 9/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Nervous system disorders Migraine	5.0% 2/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Reproductive system and breast disorders Dysmenorrhoea	17.5% 7/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Skin and subcutaneous tissue disorders Eczema	5.0% 2/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Skin and subcutaneous tissue disorders Rash erythematous	5.0% 2/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
Skin and subcutaneous tissue disorders Skin irritation	92.5% 37/40 • Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: disclosure@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to submitting or presenting a manuscript, the investigator shall provide to LEO Pharma a copy of all such manuscripts, and LEO Pharma shall have rights to review and comment. Upon the request of LEO Pharma the investigator shall remove any confidential information prior to submitting or presenting the manuscripts. The investigator shall, upon the request of LEO Pharma, delay publication or presentation to allow LEO Pharma to protect its inventions and other intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER