Combination Treatment for Moderate to Severe Acne

Acne Clinical Trial

Official title:

A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206348
• Other study ID #: MP-0104-28
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2010
• Last updated: November 28, 2011
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne

Description:

A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)

Exclusion Criteria:

• pregnancy and allergies

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Global Service Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients showing improvement from Baseline and Week 12		Week 12	No