Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01425320
• Other study ID #: 225678-003
• Status: Withdrawn
• Phase: Phase 1
• First received: August 26, 2011
• Last updated: November 16, 2012
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate the pharmacokinetics, safety and tolerability of dapsone and adapalene following topical administration of 2 formulations of dapsone/adapalene fixed combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects with acne vulgaris.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Moderate acne on the face

• Willing to avoid swimming during the study

• Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during the study

• Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the study

Exclusion Criteria:

• Severe cystic acne

• Use of topical or oral retinoids within 4 weeks

• Use of isotretinoin within 3 months

• Use of dapsone or adapalene within 3 months

• Anticipated need to engage in activities/exercise that would cause profuse sweating

• Donated blood or equivalent blood loss within 90 days

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Fixed Combination dapsone/adapalene Formulation A Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
• Fixed Combination dapsone/adapalene Formulation B Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
• dapsone 5% gel
Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
• adapalene 0.3% gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Levels of Dapsone		Day 1	No
Primary	Plasma Levels of Dapsone		Day 14	No
Primary	Plasma Levels of Adapalene		Day 1	No
Primary	Plasma Levels of Adapalene		Day 14	No
Secondary	Local Dermal Tolerability Rating Using a 4-Point Scale		Day 14	No