Clinical Trials

Multiple clinical trials evaluate the therapeutic and pharmacological properties of desonide for dermatological conditions, including atopic dermatitis, eczema, psoriasis, axillary hyperpigmentation, and cutaneous vasoconstriction. Spanning Phase I through Phase IV and non-applicable designs, these completed, recruiting, unknown, and withdrawn studies are supported by academic medical centers and commercial sponsors, including Procter & Gamble Beauty and MC2 Therapeutics. Furthermore, several clinical trials specifically assess Phase IV desonide formulations for pediatric atopic dermatitis and hyperpigmentation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03437005 RECRUITING
Healthy
University of California, Davis
 2013-01-28 PHASE1
NCT03758365 COMPLETED
Vasoconstriction
MC2 Therapeutics
 2018-11-05 PHASE1
NCT03386032 COMPLETED
Atopic Dermatitis Eczema
Procter and Gamble
 2017-11-27 PHASE3
NCT02732314 COMPLETED
Dermatitis, Atopic; Eczema
Procter & Gamble Beauty
 2016-03 PHASE4
NCT02624544 WITHDRAWN
Psoriasis
EMS
 2016-01 PHASE4
NCT02286700 UNKNOWN
Dermatitis, Atopic; Eczema
NeoStrata Company, Inc.
 2014-11 PHASE3
NCT02286700 Unknown status
Dermatitis Atopic|Eczema
NeoStrata Company Inc.|Massachusetts General Hospital
 2014-11 Phase 3
NCT01542138 COMPLETED
Hyperpigmentation
Universidad Autonoma de San Luis Potosí
 2011-07 PHASE4
NCT01467362 COMPLETED
Atopic Dermatitis
Pierre Fabre Medicament
 2011-11 PHASE3
NCT03397979 Completed
Atopic Dermatitis
MaineHealth
 2011-11-14 Not Applicable
NCT00828412 COMPLETED
Atopic Dermatitis
Promius Pharma, LLC
 2009-03 PHASE4
NCT00690833 COMPLETED
Atopic Dermatitis
Wake Forest University
 2007-08 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-02-20)

Check the Desonide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a low-potency topical corticosteroid, desonide binds to intracellular glucocorticoid receptors, inducing nuclear translocation to suppress the expression of pro-inflammatory cytokines and mediators. This targeted inhibition reduces localized immune activation and cellular inflammatory responses, thereby mitigating skin inflammation and cutaneous symptom severity in clinical conditions such as atopic dermatitis, eczema, and psoriasis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.