A Phase 3 interventional study of Tacrolimus Ointment 0.1% and Protopic® ointment, 0.1% in Atopic Dermatitis, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 60 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 3, Interventional, and Treatment
Among 26 studies testing tacrolimus in Dermatitis, Atopic — 4 open to participants now, 4 under way, 1 of them phase 3. Tacrolimus · Dermatitis, Atopic.
Among the 26 studies testing tacrolimus in Dermatitis, Atopic, this one has the largest enrollment, is the only one that started in 2015, is one of 8 in phase 3, and was the 21st registered.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 1,110 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →4 of the 26 studies testing tacrolimus in Dermatitis, Atopic are open now, in 2 countries. Each count lists the studies.
Tacrolimus: first FDA approval 1994 (PROGRAF), first EMA approval 2002. 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: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2015.
Median enrollment 196 across the 26 interventional studies. Of the 22 that completed or were terminated, 1 (5%) have results posted.
20 of 26 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.
2 of the studies testing tacrolimus in Dermatitis, Atopic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07162896Phase 3Shalamar Institute of Health SciencesCrisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis | 2027-01 |
| NCT07519174Foundation University IslamabadA Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 Weeks | 2026-11-01 |
Among the 26 studies testing tacrolimus 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 Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
Key Inclusion Criteria:
Key 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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tacrolimus Ointment 0.1%
Drug: Protopic® ointment, 0.1%
Drug: Placebo of Tacrolimus Ointment
apply thin layer of ointment to affected area
apply thin layer of ointment to affected area
apply thin layer of ointment to affected area
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
Time frame: Day 15
The change in severity score from baseline to study Day 15 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: Tacrolimus
Glenmark Pharmaceuticals Ltd. India