Placebo Gel (NINR)

Placebo Gel (NINR) refers to the inactive control formulation used in a Phase 2 randomized, double-blind clinical trial (NCT00075023) conducted by the National Institute of Nursing Research (NINR). This placebo was utilized to evaluate the efficacy of topical thalidomide gel for the treatment of ulcerative stomatitis associated with chronic graft-versus-host disease (cGVHD). The formulation consisted of Orabase plain, a dental paste vehicle composed of gelatin, pectin, and sodium carboxymethylcellulose in a plasticized hydrocarbon gel base, which served as the vehicle without the active ingredient thalidomide. In the clinical study, the gel was applied topically to oral ulcers four times daily for a duration of four weeks to provide a comparative baseline for assessing the therapeutic effects and safety of the active thalidomide treatment.

Brand names

Orabase

Other names

Placebo GelOrabase plainplacebo gel-National Institute of Nursing Research (NINR)-stomatitis