Trial · NCT02828241

A Study to Assess the Efficacy, Safety and Tolerability of DFD-04

NCT02828241, Phase 2, Completed, Dr. Reddy's Laboratories Limited, India; results first posted 2019-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Efficacy, Safety and Tolerability of DFD-04. Trials, record NCT02828241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02828241

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Efficacy, Safety and Tolerability of DFD-04
NCT number: NCT02828241
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: Dr. Reddy's Laboratories Limited, India
Conditions: Rosacea
Interventions: DFD-04 Ointment, Placebo Ointment
First posted: 2016-07-11
Last updated: 2019-01-23
Results first posted: 2019-01-23
Limitations and caveats: Phase 2 pilot study so sample size was small.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Inflammatory Lesion Counts	At the end of study (12 weeks)	Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.
Primary	Number of Subjects With Investigator's Global Assessment (IGA) Success	At the end of study (12 weeks)	Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.
Primary	Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale	At end of study (12 weeks)	Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Inflammatory Lesion Counts	At the end of study (12 weeks)	Intent to Treat (ITT)	Number of lesions	MEAN
PRIMARY	Number of Subjects With Investigator's Global Assessment (IGA) Success	At the end of study (12 weeks)	Intent to Treat (ITT) population	participants	NUMBER
PRIMARY	Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale	At end of study (12 weeks)	ITT population	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Inflammatory Lesion Counts	DFD-04 Ointment	-1.4	Standard Deviation 13.8	Number of lesions
Change in Inflammatory Lesion Counts	Placebo Ointment	2.9	Standard Deviation 17.5	Number of lesions
Number of Subjects With Investigator's Global Assessment (IGA) Success	DFD-04 Ointment	3		participants
Number of Subjects With Investigator's Global Assessment (IGA) Success	Placebo Ointment	2		participants
Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale	DFD-04 Ointment	2		participants
Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale	Placebo Ointment	2		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	DFD-04 Ointment	38
Overall Study	STARTED	Placebo Ointment	23
Overall Study	COMPLETED	DFD-04 Ointment	30
Overall Study	COMPLETED	Placebo Ointment	21
Overall Study	NOT COMPLETED	DFD-04 Ointment	8
Overall Study	NOT COMPLETED	Placebo Ointment	2

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Any Gastrointestinal Disorder	Gastrointestinal disorders	DFD-04 Ointment	4	38	7
other	Any Gastrointestinal Disorder	Gastrointestinal disorders	Placebo Ointment	3	23	6
other	Any General Disorder and Administrative Site Condition	General disorders	DFD-04 Ointment	29	38	127
other	Any General Disorder and Administrative Site Condition	General disorders	Placebo Ointment	13	23	36
other	Any Infections and Infestations	Infections and infestations	DFD-04 Ointment	12	38	16
other	Any Infections and Infestations	Infections and infestations	Placebo Ointment	7	23	11
other	Any Investigations	Investigations	DFD-04 Ointment	2	38	5
other	Any Investigations	Investigations	Placebo Ointment	1	23	1
other	Any Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	DFD-04 Ointment	2	38	2
other	Any Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	Placebo Ointment	0	23	0

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DFD-04 Ointment	0	38
Total, all-cause mortality	Placebo Ointment	0	23
Total, other adverse events	DFD-04 Ointment	37	38
Total, other adverse events	Placebo Ointment	19	23
Total, serious adverse events	DFD-04 Ointment	0	38
Total, serious adverse events	Placebo Ointment	0	23

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
DFD-04 Ointment vs Placebo Ointment: Number of Subjects With Investigator's Global Assessment (IGA) Success	Trial comparisons
DFD-04 Ointment vs Placebo Ointment: Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale	Trial comparisons
DFD-04 Ointment vs Placebo Ointment: deaths from any cause	Trial comparisons
DFD-04 Ointment vs Placebo Ointment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02828241

GET https://conductscience.org/api/trials/v1/NCT02828241/events?page=2

API reference For AI assistants