Atopic Dermatitis (AD)Phase 4CRISA-ADNCT07438509
Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema
A Phase 4 study testing Crisaborole 2% Cream in people with Atopic Dermatitis (AD) and Atopic Eczema, run by Jinnah Postgraduate Medical Centre.
Trial summary
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Atopic Dermatitis (AD), Atopic Eczema
- What is being tested?
- Crisaborole 2% Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12 to 50 years
- Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)
- Willing and able to apply topical medication twice daily for four weeks
- Able to provide written informed consent (parental consent for participants under 18 years)
Who cannot join
- Severe atopic dermatitis (ISGA score 4)
- Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks
- Known hypersensitivity to crisaborole or any component of the formulation
- Pregnant or lactating women
- Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
- Immunocompromised status (e.g., HIV infection, organ transplant recipient)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of Crisaborole 2% Cream Compared to Placebo in the Management of Mild to Moderate Atopic Eczema
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life.
Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline.
Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.
Read the detailed description
Atopic dermatitis (AD), commonly referred to as atopic eczema, is a chronic, relapsing inflammatory skin disorder characterized by pruritus, erythema, and impaired skin barrier function. AD affects both children and adults and is associated with significant psychosocial burden, sleep disturbance, and reduced quality of life. Standard treatment options include topical corticosteroids and calcineurin inhibitors; however, prolonged use of these agents may be associated with adverse effects such as skin atrophy, irritation, and tachyphylaxis, highlighting the need for effective non-steroidal alternatives.
Crisaborole 2% cream is a topical phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by inhibiting cyclic adenosine monophosphate degradation and decreasing pro-inflammatory cytokine production. International clinical trials have demonstrated its efficacy in mild to moderate AD, but limited data are available from South Asian populations.
This study is a single-center, randomized, placebo-controlled trial conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi. Participants aged 12 to 50 years with clinically diagnosed mild to moderate AD, defined by an ISGA score of 2 (mild) or 3 (moderate), will be enrolled after obtaining written informed consent.
Participants will be randomized in a 1:1 ratio into two groups:
Group A: Crisaborole 2% cream applied twice daily
Group B: Placebo cream applied twice daily
The treatment duration will be four weeks. Clinical assessments will be conducted at baseline, Day 14, and Day 28. The primary endpoint is treatment success at Day 28, defined as achieving an ISGA score of 0 or 1 with at least a two-grade improvement from baseline.
Secondary evaluations will include safety assessment, monitoring of adverse events, and treatment adherence. Comparative analysis will determine whether Crisaborole 2% cream provides superior efficacy compared with placebo in managing mild to moderate AD.
- Conditions
- Atopic Dermatitis (AD), Atopic Eczema
- Being tested
- Placebo Cream, Crisaborole 2% Cream
- Keywords
- Mild to Moderate Atopic Dermatitis, Crisaborole, Phosphodiesterase-4 Inhibitor, Topical Therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo CreamDrug
Non-medicated topical cream identical in appearance and packaging to Crisaborole 2% cream, applied twice daily for four weeks.
Crisaborole 2% CreamDrug
Crisaborole 2% Cream
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole 2% Cream | Experimental | Participants will apply Crisaborole 2% cream as a thin layer to affected areas twice daily for four weeks. Receives: Drug: Crisaborole 2% Cream |
| Placebo Cream | Placebo comparator | Participants will apply a placebo cream identical in appearance and consistency to Crisaborole 2% cream, twice daily for four weeks. Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)
Treatment success is defined as achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline.
Measured: Day 28 (End of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either Crisaborole 2% cream or placebo cream applied twice daily for four weeks. Each participant will remain in the assigned group throughout the study period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Uroosa Shailkh, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438509
- Sponsor's protocol ID
- JPMC-CRISA-2026-01
- Acronym
- CRISA-AD
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in the manuscript, including baseline characteristics, ISGA scores, and outcome measures after de-identification.
Publications
8. Fowler JF, Hebert AA, Del Rosso JQ. Patient-reported outcomes of crisaborole treatment in real-world settings. Clin Cosmet Investig Dermatol. 2021;14:1443-1452.
7. Paller AS, Tom WL, Eichenfield LF. Efficacy of crisaborole ointment in pediatric patients with mild-to-moderate atopic dermatitis. JAMA Dermatol. 2020;156(5):556-563
6. Eichenfield LF, Tom WL, Chamlin SL. Evaluation of the safety and efficacy of crisaborole ointment for the treatment of atopic dermatitis in children and adolescents: results from two phase 3 studies. J Am Acad Dermatol. 2021;85(4):892-900.
5. Kaul S, Blauvelt A. Crisaborole: a nonsteroidal topical treatment for atopic dermatitis. Dermatol Ther. 2020;10(1):15-22.
4. Blauvelt A, Simpson EL, Tyring SK, et al. Long-term management of atopic dermatitis: perspectives on current and emerging topical treatments. J Am Acad Dermatol. 2023;88(4):1001-1010.
3. Kim JP, Chao LX, Simpson EL. Psychosocial burden of atopic dermatitis: A systematic review. Clin Dermatol. 2022;40(6):452-459
2. Mahmood K, Akhtar F, Hussain M. Pattern and frequency of atopic dermatitis in Pakistani children: a multicenter cross-sectional study. Pak J Med Sci. 2021;37(3):891-895
1. Odhiambo JA, Asher MI, Williams HC. Global variations in prevalence and severity of eczema symptoms in children. Int J Dermatol. 2020;59(5):582-589
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Crisaborole 2% Cream Compared to Placebo in the Management of Mild to Moderate Atopic Eczema
- ClinicalTrials.gov ID
- NCT07438509
- Acronym / sponsor ID
- CRISA-AD / JPMC-CRISA-2026-01
- Conditions
- Atopic Dermatitis (AD), Atopic Eczema
- Keywords
- Mild to Moderate Atopic Dermatitis, Crisaborole, Phosphodiesterase-4 Inhibitor, Topical Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life.
Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline.
Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.
Detailed description
Atopic dermatitis (AD), commonly referred to as atopic eczema, is a chronic, relapsing inflammatory skin disorder characterized by pruritus, erythema, and impaired skin barrier function. AD affects both children and adults and is associated with significant psychosocial burden, sleep disturbance, and reduced quality of life. Standard treatment options include topical corticosteroids and calcineurin inhibitors; however, prolonged use of these agents may be associated with adverse effects such as skin atrophy, irritation, and tachyphylaxis, highlighting the need for effective non-steroidal alternatives.
Crisaborole 2% cream is a topical phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation by inhibiting cyclic adenosine monophosphate degradation and decreasing pro-inflammatory cytokine production. International clinical trials have demonstrated its efficacy in mild to moderate AD, but limited data are available from South Asian populations.
This study is a single-center, randomized, placebo-controlled trial conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi. Participants aged 12 to 50 years with clinically diagnosed mild to moderate AD, defined by an ISGA score of 2 (mild) or 3 (moderate), will be enrolled after obtaining written informed consent.
Participants will be randomized in a 1:1 ratio into two groups:
Group A: Crisaborole 2% cream applied twice daily
Group B: Placebo cream applied twice daily
The treatment duration will be four weeks. Clinical assessments will be conducted at baseline, Day 14, and Day 28. The primary endpoint is treatment success at Day 28, defined as achieving an ISGA score of 0 or 1 with at least a two-grade improvement from baseline.
Secondary evaluations will include safety assessment, monitoring of adverse events, and treatment adherence. Comparative analysis will determine whether Crisaborole 2% cream provides superior efficacy compared with placebo in managing mild to moderate AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either Crisaborole 2% cream or placebo cream applied twice daily for four weeks. Each participant will remain in the assigned group throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Crisaborole 2% Cream | Experimental | Drug: Crisaborole 2% CreamParticipants will apply Crisaborole 2% cream as a thin layer to affected areas twice daily for four weeks. |
| Placebo Cream | Placebo comparator | Drug: Placebo CreamParticipants will apply a placebo cream identical in appearance and consistency to Crisaborole 2% cream, twice daily for four weeks. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12 to 50 years
- Clinically diagnosed mild to moderate atopic dermatitis (ISGA score 2 or 3)
- Willing and able to apply topical medication twice daily for four weeks
- Able to provide written informed consent (parental consent for participants under 18 years)
Key exclusion criteria (6 listed)
- Severe atopic dermatitis (ISGA score 4)
- Use of systemic corticosteroids, immunosuppressants, or antibiotics within the past two weeks
- Known hypersensitivity to crisaborole or any component of the formulation
- Pregnant or lactating women
- Presence of other significant dermatological conditions that may interfere with evaluation (e.g., psoriasis, scabies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo CreamNon-medicated topical cream identical in appearance and packaging to Crisaborole 2% cream, applied twice daily for four weeks. | Drug | Placebo Cream |
| Crisaborole 2% CreamCrisaborole 2% Cream | Drug | Crisaborole 2% Cream |
Primary outcome
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA)
Time frame: Day 28 (End of Treatment)
Treatment success is defined as achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication8. Fowler JF, Hebert AA, Del Rosso JQ. Patient-reported outcomes of crisaborole treatment in real-world settings. Clin Cosmet Investig Dermatol. 2021;14:1443-1452.
- Results publication7. Paller AS, Tom WL, Eichenfield LF. Efficacy of crisaborole ointment in pediatric patients with mild-to-moderate atopic dermatitis. JAMA Dermatol. 2020;156(5):556-563
- Results publication6. Eichenfield LF, Tom WL, Chamlin SL. Evaluation of the safety and efficacy of crisaborole ointment for the treatment of atopic dermatitis in children and adolescents: results from two phase 3 studies. J Am Acad Dermatol. 2021;85(4):892-900.
- Results publication5. Kaul S, Blauvelt A. Crisaborole: a nonsteroidal topical treatment for atopic dermatitis. Dermatol Ther. 2020;10(1):15-22.
- Results publication4. Blauvelt A, Simpson EL, Tyring SK, et al. Long-term management of atopic dermatitis: perspectives on current and emerging topical treatments. J Am Acad Dermatol. 2023;88(4):1001-1010.
- Results publication3. Kim JP, Chao LX, Simpson EL. Psychosocial burden of atopic dermatitis: A systematic review. Clin Dermatol. 2022;40(6):452-459
- Results publication2. Mahmood K, Akhtar F, Hussain M. Pattern and frequency of atopic dermatitis in Pakistani children: a multicenter cross-sectional study. Pak J Med Sci. 2021;37(3):891-895
- Results publication1. Odhiambo JA, Asher MI, Williams HC. Global variations in prevalence and severity of eczema symptoms in children. Int J Dermatol. 2020;59(5):582-589
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in the manuscript, including baseline characteristics, ISGA scores, and outcome measures after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crisaborole 2% Cream in people with Atopic Dermatitis (AD) and Atopic Eczema, run by Jinnah Postgraduate Medical Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uroosa Shaikh, FCPS (03366601694, uroosashaikh654@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Treatment Success Based on Investigator's Static Global Assessment (ISGA) (time frame: Day 28 (End of Treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438509, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.