Verification of the effectiveness of the combination therapy with an oral antibiotics and Adapalene for the treatment of acne vulgaris.

UMIN ID: UMIN000003415

Registered date:31/03/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: acne vulgaris
• Date of first enrollment: 2010/02/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks. In the first 2 weeks, Faropenem Sodium Hydrate will be also administered three times daily.
Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks. In parallel with this treatment, Faropenem Sodium Hydrate will be also administered three times daily for 4 weeks.
Adapalene gel will be applied to the surface of the face overall once daily after washing the face before retiring in the evening for 4 weeks.

Outcome(s)

• Primary Outcome: Decrease percentage of the number of inflammatory lesion.
• Secondary Outcome: -Change of the number of inflammatory lesion and comedone -Safety -Change in patient QOL(Skindex-16)

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients taking some drugs(oral,topical or injective agents)expected to be indicated for the treatment of acne within 4 weeks 2) Patients with hypersensitivity to any of the study drugs 3) Patients continuously receiving non-steroidal anti-inflammatory drugs 4) Women who are pregnant,might be pregnant or lactating 5) Patients who are considered unsuitable for this study by the investigator

Related Information

• Primary Sponsor: Tokyo Woman's Medical University
• Source(s) of Monetary Support: Non-Profit Organization Health Institute Research of Skin