Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106807

Enrollment

Registered

2010-04-20

Start date

2010-04-30

Completion date

2010-09-30

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Brief summary

The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

Interventions

DRUGEpiduo vehicle gel

500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks

DRUGCD07223

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks

DRUGEpiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

500 microliters Epiduo Gel on one of the half-face for the morning dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Inclusion criteria

* subject has a clinical diagnosis of acne vulgaris with facial involvement * the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion criteria

* subject has a severe acne form or secondary acne form * the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face * the subject has a known allergy or sensitivity to any of the components of the study products * subject is not willing to respect wash-out periods for topical and/or systemic treatments

Design outcomes

Primary

Measure	Time frame	Description
Total acne lesion count	6 weeks	change in total number of acne lesion count from baseline to end of treatment
Percent change of acne lesion count	6 weeks	Percent change of acne lesion count from baseline to end of treatment

Secondary

Measure	Time frame	Description
Lesion counts- Inflammatory	6 weeks	change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Lesion count- non-inflammatory	6 weeks	change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026