A Phase 3 interventional study of Pimecrolimus Cream, 1% and Elidel® (pimecrolimus) Cream in Atopic Dermatitis, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 27 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 3, Interventional, and Treatment
Among 27 studies testing pimecrolimus in Dermatitis, Atopic — none open to participants now, none under way, none of them phase 3. pimecrolimus · Dermatitis, Atopic.
Among the 27 studies testing pimecrolimus in Dermatitis, Atopic, this one is the 3rd largest by enrollment of the 24 interventional ones, is one of 2 that started in 2016, is one of 6 in phase 3, and was the 25th registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 755 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →None of the 27 studies testing pimecrolimus in Dermatitis, Atopic is open now.
pimecrolimus: first FDA approval 2001 (ELIDEL). What it is approved for, and how studies give it, is on its page →
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →27 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2016.
Median enrollment 113 across the 24 interventional studies. Of the 27 that completed or were terminated, 4 (15%) have results posted.
22 of 27 have an industry lead sponsor. The 10 most frequent:
Glenmark Pharmaceuticals Ltd. India is the lead sponsor of 16 studies on the registry; none are open to participants now.
Glenmark Pharmaceuticals Ltd. India has 2 studies filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 27 studies testing pimecrolimus in Dermatitis, Atopic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application
Drug: Pimecrolimus Cream, 1%
Elidel® (Valeant Pharmaceuticals North America LLC) topical application
Drug: Elidel® (pimecrolimus) Cream
Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application
Drug: Placebo of Pimecrolimus Cream, 1%
The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).
Time frame: Day 15
Change in severity score from baseline to Visit 3 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).
Time frame: Day 15
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pimecrolimus
Glenmark Pharmaceuticals Ltd. India