A Phase 2 interventional study of DFD-29 Extended Release Capsules (40 mg) and DFD-29 Extended Release Capsules (20 mg) in Rosacea, sponsored by Dr. Reddy's Laboratories Limited. Completed at 14 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by Dr. Reddy's Laboratories Limited · Phase 2, Interventional, and Treatment
Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.
Two hundred (200) male and female subjects with papulopustular rosacea will be enrolled to get 176 completed subjects (forty-four (44) completers each in groups 1 to 4).
After assessing eligibility during an up to 28 days screening period, 200 subjects will be enrolled in the study (fifty subjects each in groups 1 to 4). Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 4, 8, 12 and 16.
Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Additionally, high sensitivity C-reactive protein (hs-CRP) in the blood will be assessed at Baseline, and at Week 16 to explore any impact of the treatment on the inflammatory pathology.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 205 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
Drug: DFD-29 Extended Release Capsules (40 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Drug: DFD-29 Extended Release Capsules (20 mg)
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Drug: Oraycea® (doxycycline) Capsules
Placebo Capsules once per day for 16 weeks.
Drug: Placebo Capsules
Oral Treatment
Oral Treatment
Oral Treatment
Oral Treatment
Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
Time frame: 16 weeks
Total Inflammatory Lesion Count Reduction
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
Time frame: 16 Weeks
Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16
The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.
Time frame: Median change in the score from Baseline to Week 16
| Milestone | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules |
|---|---|---|---|---|
| Started | 53 | 50 | 49 | 53 |
| Completed | 47 | 38 | 40 | 35 |
| Not completed | 6 | 12 | 9 | 18 |
| Withdrew: Adverse event | 1 | 3 | 2 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 | 4 | 7 |
| Withdrew: Use of prohibited treatment | 0 | 3 | 2 | 4 |
| Withdrew: Wrongful enrollment (i/e criteria not me | 0 | 1 | 0 | 1 |
| Withdrew: Subject developed an exclusion criterion | 0 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 1 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 1 |
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
| Participants | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules |
|---|---|---|---|---|
| Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe | 35 | 15 | 16 | 6 |
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
| Count of lesions | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules |
|---|---|---|---|---|
| Total Inflammatory Lesion Count Reduction | -19.2 ± 9.72 | -12.6 ± 12.92 | -10.5 ± 15.18 | -7.3 ± 10.12 |
The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.
| score on a scale | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules |
|---|---|---|---|---|
| Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16 | -11.0 (-53 to 11) | -8.0 (-34 to 8) | -3.0 (-30 to 25) | -1.0 (-37 to 19) |
Collected over AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | 0/52 (0%) | 1/52 (1.9%) | 37/52 (71.2%) |
| DFD-29 Extended Release Capsules (20 mg) | 0/48 (0%) | 2/48 (4.2%) | 33/48 (68.8%) |
| Oraycea® (Doxycycline) Capsules | 0/48 (0%) | 2/48 (4.2%) | 27/48 (56.3%) |
| Placebo Capsules | 0/53 (0%) | 0/53 (0%) | 35/53 (66%) |
| Event | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/52 | 1/48 | 0/48 | 0/53 |
| LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/52 | 0/48 | 1/48 | 0/53 |
| PapillomaNervous system disorders | 0/52 | 0/48 | 1/48 | 0/53 |
| Retinal detachmentEye disorders | 0/52 | 1/48 | 0/48 | 0/53 |
| Coronary artery diseaseCardiac disorders | 1/52 | 0/48 | 0/48 | 0/53 |
| Event | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules |
|---|---|---|---|---|
| HeadacheNervous system disorders | 22/52 | 14/48 | 13/48 | 13/53 |
| NasopharyngitisInvestigations | 11/52 | 8/48 | 7/48 | 6/35 |
| Back PainMusculoskeletal and connective tissue disorders | 0/52 | 4/48 | 4/48 | 6/53 |
| DiarrhoeaGastrointestinal disorders | 4/52 | 4/48 | 0/48 | 3/53 |
| RosaceaSkin and subcutaneous tissue disorders | 0/52 | 0/48 | 0/48 | 4/53 |
| Abdominal Pain UpperGastrointestinal disorders | 0/52 | 3/48 | 3/48 | 3/53 |
The FAS (full analysis set) had all subjects who had at least one post Baseline efficacy assessment.
| Age, Categorical(Participants) | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 40 | 40 | 42 | 167 |
| >=65 years | 8 | 10 | 9 | 11 | 38 |
| Age, Continuous(years) | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules | Total |
|---|---|---|---|---|---|
| Mean | 46.8 ± 15.05 | 51.1 ± 13.13 | 51.6 ± 12.94 | 52.5 ± 12.92 | 50.5 ± 13.64 |
| Sex: Female, Male(Participants) | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules | Total |
|---|---|---|---|---|---|
| Female | 34 | 34 | 29 | 27 | 124 |
| Male | 19 | 16 | 20 | 26 | 81 |
| Race (NIH/OMB)(Participants) | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 53 | 50 | 49 | 53 | 205 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules | Total |
|---|---|---|---|---|---|
| Germany | 53 | 50 | 49 | 53 | 205 |
| Total Inflammatory Lesion Count(Number of lesions) | DFD-29 Extended Release Capsules (40 mg) | DFD-29 Extended Release Capsules (20 mg) | Oraycea® (Doxycycline) Capsules | Placebo Capsules | Total |
|---|---|---|---|---|---|
| Mean | 23.8 ± 8.69 | 24.5 ± 9.49 | 23.8 ± 7.56 | 24.0 ± 8.40 | 24.0 ± 8.51 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Nov 2018, 13 months.
Results were first posted in Apr 2020, 1 year 5 months after primary completion.
Of 20 phase 2 interventional studies under Rosacea, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 16. This study's 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: DFD-29 · Doxycycline
Dr. Reddy's Laboratories Limited →