NCT01111994

Brief Summary

The purpose of this study is ascertain the efficacy and safety of Clindamycin Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post Inflammatory Hyperpigmentation in patients with skin of color.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
Last Updated

May 20, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

April 26, 2010

Last Update Submit

May 19, 2010

Conditions

Acne

Keywords

hyperpigmentation

Outcome Measures

Primary Outcomes (1)

  • Improvement of acne and post inflammatory hyperpigmentation

    3 months

Interventions

Clindamycin Phosphate 1.2% and Tretinoin 0.025% GelDRUG

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months

Also known as: Ziana Gel

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
  • Photo skin types IV - VI
  • Ages 12 and older
  • Both sexes
  • Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
  • Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives

You may not qualify if:

  • Seborrheic dermatitis
  • PIH of solely dermal origin
  • Acne vulfaris known to be resistant to oral antibiotics
  • Use of erythromycin-containing products
  • Use of neuromuscular blocking agents
  • Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Callender Center for Clinical Research

Mitchellville, Maryland, 20721, United States

Location

Society Hill Dermatology

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Acne VulgarisHyperpigmentation

Interventions

clindamycin phosphateTretinoinGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesPigmentation Disorders

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Valerie Callender, MD

    Callender Center for Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

May 20, 2010

Record last verified: 2010-05

Locations

US(2)