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CompletedNCT02070965BDS1307Updated Mar 7, 2024Results posted

DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

A Phase 2 interventional study of DFD01 Spray and Comp01 Lotion in Plaque Psoriasis, sponsored by Primus Pharmaceuticals. Completed at 12 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Primus Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.

02

Conditions studied

  • Plaque Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Primus Pharmaceuticals is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
  2. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
  3. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit
  4. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response. -

Exclusion criteria

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  3. Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
  4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
  5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
  6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
  7. Subjects who have an abnormal sleep schedule or work at night.
  8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
  9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    DFD01 Spray Group 1

    DFD01 Spray, bid, 28 days

    Drug: DFD01 Spray

  • Active comparator
    Comp01 Lotion

    Comp01 Lotion, bid, 14 days

    Drug: Comp01 Lotion

  • Experimental
    DFD01 Spray Group 2

    DFD01 Spray, bid, 14 days

    Drug: DFD01 Spray

Interventions

  • DrugDFD01 Spray
  • DrugComp01 Lotion
06

What researchers measure

Primary outcomes

  1. The Number of Subjects With HPA Axis Suppression

    Time frame: Day 15

07

Results

Posted Mar 13, 2017

Participant flow

Participant flow — Overall Study
MilestoneDFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2
Started272325
Completed252124
Not completed221
Withdrew: Lost to follow-up010
Withdrew: Withdrawal by subject111
Withdrew: Subject moved100

Outcome measures

PrimaryThe Number of Subjects With HPA Axis Suppression
Time frame:
Day 15
Reported as:
Count of participants · Participants
The Number of Subjects With HPA Axis Suppression
ParticipantsDFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2
The Number of Subjects With HPA Axis Suppression055

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
DFD01 Spray Group 1—0/27 (0%)2/27 (7.4%)
Comp01 Lotion—0/22 (0%)6/22 (27.3%)
DFD01 Spray Group 2—0/25 (0%)8/25 (32%)
Most frequent other events
Most frequent other events
EventDFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2
HPA Axis SuppressionEndocrine disorders0/275/225/25
HeadacheNervous system disorders0/270/222/25
Application Site PruritusGeneral disorders2/271/221/25

Baseline characteristics

One subject signed informed consent and was randomized but was lost to follow up and, therefore, provided no baseline or post-baseline data.

Age, Continuous
Age, Continuous(years)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
Mean46.8 ± 9.9945.4 ± 11.3247.6 ± 13.7146.7 ± 11.55
Sex: Female, Male
Sex: Female, Male(Participants)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
Female66921
Male21161653
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
American Indian or Alaska Native0000
Asian1124
Native Hawaiian or Other Pacific Islander0000
Black or African American2136
White24202064
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
United States27222574
Percent Body Surface Area (BSA) involved
Percent Body Surface Area (BSA) involved(Percent BSA affected)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
Mean26.5 ± 8.6126.8 ± 6.3229.0 ± 11.0427.4 ± 8.90
Investigator's Global Assessment (IGA)
Investigator's Global Assessment (IGA)(Participants)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
IGA 3 (Moderate)20212263
IGA 4 (Severe/Very Severe)71311
Normal Adrenal Corticotropic Hormone (ACTH) test
Normal Adrenal Corticotropic Hormone (ACTH) test(Participants)DFD01 Spray Group 1Comp01 LotionDFD01 Spray Group 2Total
Count of participants27222574
08

Study locations

12 sites
  • California Dermatology and Clinical Research Institute
    Encinitas, California 92024, United States
  • Encino Research Center T. Joseph Raoof MD, Inc.
    Encino, California 91436, United States
  • Redwood Dermatology Research
    Santa Rosa, California 95403, United States
  • Bettencourt Skin Center
    Henderson, Nevada 89074, United States
  • Academic Dermatology Associates
    Albuquerque, New Mexico 87106, United States
  • Dermatology Consulting Services
    High Point, North Carolina 27262, United States
  • Paddington Testing Company, Inc.
    Philadelphia, Pennsylvania 19101, United States
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
  • DermResearch, Inc.
    Austin, Texas 78759, United States
  • Center for Clinical Studies, LTD. LLP
    Houston, Texas 77004, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • Suzanne Bruce and Associates, PA The Center for Skin Research Katy/Cinco Ranch
    Katy, Texas 77494, United States
09

References and documents

Publications

  • Sidgiddi S, Pakunlu RI, Allenby K. Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1. PubMed 29657667 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02070965
Lead sponsor
Primus Pharmaceuticals
Collaborators
Prosoft Clinical
Responsible party
Sponsor
First posted
Feb 25, 2014
Start date
Jan 2014
Primary completion
Oct 2014
Completion
Oct 2014
Results posted
Mar 13, 2017
Last update
Mar 7, 2024
View the source record on ClinicalTrials.gov ↗

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