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CompletedNCT00989014Updated Feb 18, 2021Results posted

Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

A Phase 2 interventional study of CD07805/47 and CD07805/47 in Erythematotelangiectatic Rosacea, sponsored by Galderma R&D. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Galderma R&D · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

02

Conditions studied

  • Erythematotelangiectatic Rosacea

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Keywords

  • Erythematotelangiectatic
  • Rosacea
03

In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's enrollment of 122 is above the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female who is at least 18 years of age.
  • Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
  • CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
  • PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
  • Presence of 2 or fewer inflammatory facial lesions.

Exclusion criteria

Exclusion Criteria:

  • History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
  • History of refractive surgery such as photorefractive keratectomy.
  • The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
  • The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    CD07805/47 0.5% Topical Gel

    0.5% Topical Gel

    Drug: CD07805/47

  • Experimental
    CD07805/47 0.18% Topical Gel

    0.18% Topical Gel

    Drug: CD07805/47

  • Experimental
    CD07805/47 0.07% Topical Gel

    0.07% Topical Gel

    Drug: CD07805/47

  • Placebo comparator
    CD07805/47 Vehicle Topical Gel

    Vehicle Topical Gel

    Drug: CD07805/47 placebo

Interventions

  • DrugCD07805/47

    0.5% Topical Gel

  • DrugCD07805/47

    0.18% Topical Gel

  • DrugCD07805/47

    0.07% Topical Gel

  • DrugCD07805/47 placebo

    Vehicle Topical Gel

06

What researchers measure

Primary outcomes

  1. Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.

    Time frame: Baseline and every hour for 12 hours following application

07

Results

Posted Nov 21, 2013

Participant flow

Participant flow — Overall Study
MilestoneCD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical Gel
Started31312832
Completed31312832
Not completed0000

Outcome measures

PrimaryResponse Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
Time frame:
Baseline and every hour for 12 hours following application
Reported as:
Number · participants
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
participantsCD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical Gel
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.171074

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CD07805/47 0.5% Topical Gel—0/31 (0%)4/31 (12.9%)
CD07805/47 0.18% Topical Gel—0/31 (0%)1/31 (3.2%)
CD07805/47 0.07% Topical Gel—0/28 (0%)3/28 (10.7%)
CD07805/47 Vehicle Topical Gel—0/32 (0%)5/32 (15.6%)
Most frequent other events
Most frequent other events
EventCD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical Gel
HeadacheNervous system disorders3/310/310/282/32
Skin IrritationSkin and subcutaneous tissue disorders1/310/312/281/32
PruritusSkin and subcutaneous tissue disorders0/311/311/282/32

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical GelTotal
<=18 years00000
Between 18 and 65 years31302729117
>=65 years01135
Age, Continuous
Age, Continuous(years)CD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical GelTotal
Mean45.8 ± 11.8746.3 ± 12.3743.7 ± 10.7446.7 ± 13.3545.7 ± 12.06
Sex: Female, Male
Sex: Female, Male(Participants)CD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical GelTotal
Female2521222492
Male6106830
Region of Enrollment
Region of Enrollment(participants)CD07805/47 0.5% Topical GelCD07805/47 0.18% Topical GelCD07805/47 0.07% Topical GelCD07805/47 Vehicle Topical GelTotal
United States31312832122
08

Study locations

5 sites
  • Burke Pharmaceutical Research
    Hot Springs, Arkansas 71913, United States
  • Philadephia Institute of Dermatology
    Fort Washington, Pennsylvania 19034, United States
  • Derm Research, Inc
    Austin, Texas 78759, United States
  • J&S Studies
    College Station, Texas 77845, United States
  • The Education & Research Foundation
    Lynchburg, Virginia 24501, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00989014
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Oct 2, 2009
Start date
Sep 2009
Primary completion
Nov 2009
Completion
Dec 2009
Results posted
Nov 21, 2013
Last update
Feb 18, 2021

Study contacts

Michael Graeber, MD
study director · Galderma R&D

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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