Effect of CD07805/47 Gel in Rosacea Flushing

NCT02300129 | Completed Phase 2 Results

• 1 other identifier: RD.03.SPR.40225E
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of the flush of rosacea.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Total Number of Flushes for Each 2-week Period

  Day 22 and Day 36/Early termination

Study Arms (4)

CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo

EXPERIMENTAL

Period 1: Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design) Period 2 (cross-over design): Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks

Drug: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo

Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo

EXPERIMENTAL

Period 1: Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.

Drug: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo

CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47

EXPERIMENTAL

Period 1: Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.

Drug: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47

Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47

EXPERIMENTAL

Period 1: Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3. Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design). Period 2 (cross-over design): Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.

Drug: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47

Interventions

CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo DRUG

Period 1: 1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. 1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks.

CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo

Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo DRUG

Period 1: 1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks. 1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks.

Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo

CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 DRUG

Period 1: 1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of Placebo on full face once daily 7 days per week for 2 weeks. 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks.

CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47

Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 DRUG

Period 1: 1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3. 500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5. Period 2: 1g of Placebo on full face once daily 7 days per week for 2 weeks. 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks.

Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a male or female, who is at least 18 years of age or older at Screening visit.
• The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004)
• The subject had at least five flushing episodes during the last week before Screening and Baseline visits

You may not qualify if:

• The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin), or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus or actinic telangiectasia;
• The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
• The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Investigational site

Hamburg, Germany

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Galderma CPM
• Organization: Galderma R&D

clinicaltrials@galderma.com

00 33 4 93 95 70 70

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 20, 2016
• Results First Posted: October 20, 2016

Record last verified: 2016-08

Locations

DE (1)