Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis

NCT02749799 | Completed Phase 4 Results FDA Drug

• 1 other identifier: DFD-01-CD-014
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• Change in Investigator's Global Assessment Grade

  The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.

  Change from Baseline to Day 14.

• Change in Percent Body Surface Area (BSA) Involved.

  Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.

  Change from Baseline to Day 14.

• Change in Dermatology Life Quality Index (DLQI)

  DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.

  Change from Baseline to Day 14.

Study Arms (1)

DFD-01 (betamethasone dipropionate) Spray, 0.05%

EXPERIMENTAL

DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.

Drug: DFD-01 (betamethasone dipropionate) Spray, 0.05%

Interventions

DFD-01 (betamethasone dipropionate) Spray, 0.05% DRUG

DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.

Also known as: Sernivo (betamethasone dipropionate, 0.05%) Spray

DFD-01 (betamethasone dipropionate) Spray, 0.05%

Eligibility Criteria

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

You may qualify if:

• Patient understands the study procedures and agrees to participate by giving written informed consent. Patients must be willing to authorize use and disclosure of protected health information collected for the study.
• Patient must be at least 18 years of age.
• Patient must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
• At least 3% Body Surface Area involved, not including the face, scalp, groin, axillae and other intertriginous areas.
• Female patients of childbearing potential must agree to use contraception during the study which can include abstinence with an adequate secondary option should the patient become sexually active. A female is considered of childbearing potential unless she is:
• Postmenopausal for at least 12 months prior to study product administration;
• Without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to study product administration.
• Reliable methods of contraception are:
• Hormonal methods or intrauterine device in use \> 90 days prior to study product administration; or
• Barrier methods plus spermicide in use at least 14 days prior to study product administration.
• Partner has had a vasectomy at least 3 months previous to study product administration.
• Essure® that has been in place for at least 3 months before the screening visit with radiograph confirmation of fallopian tube blockage.
• Exception: Sexually inactive female patients of childbearing potential are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study. An abstinent female must agree that if she becomes sexually active during the study she will use an acceptable form of contraception.
• All women must complete a urine pregnancy test at the Baseline Visit (Day 1) and the test result must be negative to be eligible for enrollment.
• Patient must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (temperature, blood pressure and pulse).

You may not qualify if:

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
• Presence of pigmentation, extensive scarring, pigmented lesions, tattoos or sunburn that could interfere with the rating of efficacy parameters.
• History of psoriasis unresponsive to topical treatments.
• History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
• Ongoing infection (including viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds) or evidence of chronic infectious disease, history of or current system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation in the study.
• Use within 180 days before Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
• Have received treatment for any type of cancer within 5 years of the Baseline Visit, except skin cancer and cervical cancer (in situ) that are allowed if at least 1 year before the Baseline Visit.
• Use within 60 days before the Baseline Visit of: 1) systemic or topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
• Use within 30 days before the Baseline Visit of: 1) systemic corticosteroids, 2) Ultraviolet light therapy, or 3) systemic anti-inflammatory agents\* (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine). \* Over-the-counter strength non-steroidal anti-inflammatory drugs used for transitional and common aches are permitted during the study.
• Use within 14 days before the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
• History of unresolved or current hypothalamic-pituitary-adrenal suppression or significant endocrine disorder (Cushing's disease or Addison's disease) or uncontrolled diabetes.
• Patients who have participated in a study of an investigational drug 30 days before the Baseline Visit.
• Patients unable to comply with study requirements.
• Female patients who are pregnant (or planning to become pregnant) or breast-feeding.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• Prosoft Clinical: collaborator

Study Sites (4)

Site Four

Arlington Heights, Illinois, 60005, United States

Location

Site Two

New Albany, Indiana, 47150, United States

Location

Site One

Louisville, Kentucky, 40202, United States

Location

Site Three

Las Vegas, Nevada, 89129, United States

Location

MeSH Terms

Interventions

betamethasone-17,21-dipropionate; Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Srinivas Sidgiddi
• Organization: Dr. Reddys Laboratories Inc

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Srinivas Sidgiddi, MD

  Dr. Reddy's Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 25, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 7, 2024
• Results First Posted: October 5, 2020

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)