Pityriasis AlbaPhase 2/3NCT03834935
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba
A Phase 2/3 study testing Elidel (pimecrolimus 1%) and Cold Cream in people with Pityriasis Alba, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Pityriasis Alba
- What is being tested?
- Elidel (pimecrolimus 1%) and Cold Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Mar 2019to 1 Apr 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pityriasis alba Patients confirmed by a board certified dermatologist
- Age over 2 years
- Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic)
Who cannot join
- Other concomitant dermatosis (except atopic dermatitis)
- Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks
- Known allergy to pimecrolimus
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Saint Joseph University
Beirut, 166830
elio kechichian, 3079072, elio.kechichian@gmail.com
About this study
Official title: Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
Read the detailed description
Background and Rationale:
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented patches, that typically occur on the upper part of the body, especially the face. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun exposure is a triggering and accentuating factor.
PA is a common reason for dermatologic consultation due to its chronic course, frequent relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years, therefore impacting the quality of life. Emollients and mild-potency topical steroids are the mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.
Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment, another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our knowledge there is no randomized placebo-controlled trial in the literature proving the efficacy of pimecrolimus in PA.
Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis alba.
Trial design: A randomized placebo-controlled double blinded trial establishing the superiority of topical pimecrolimus 1% over placebo.
- Conditions
- Pityriasis Alba
- Being tested
- Elidel (pimecrolimus 1%), Cold Cream
- Keywords
- pityriasis alba, treatment, topical calcineurin inhibitor
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elidel (pimecrolimus 1%)Drug
topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
Cold CreamDrug
Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
| Study group | Role | What they receive |
|---|---|---|
| Pim | Experimental | 20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed. Receives: Drug: Elidel (pimecrolimus 1%) |
| Pl | Placebo comparator | 20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed. Receives: Drug: Cold Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of repigmentation of index lesions
Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)
Measured: 9 weeks
Secondary outcomes (4)
Pruritus and scaling
IGA 4 point-scale (0: none - 3: severe)
Measured: 3,6 and 9 weeks
Investigator's repigmentation change
Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).
Measured: 3,6 and 9 weeks
patient satisfaction
(0: not satisfied, 1: satisfied, 2: very satisfied).
Measured: 9 weeks
Adverse events
adverse events reporting
Measured: 3,6 and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pityriasis AlbaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elio kechichian, St Joseph University, Beirut, Lebanon
- Investigators
- Josiane Helou, MD, Study chair, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834935
- Sponsor's protocol ID
- USJDERM1
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03834935
- Acronym / sponsor ID
- USJDERM1
- Conditions
- Pityriasis Alba
- Keywords
- pityriasis alba, treatment, topical calcineurin inhibitor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 8 Feb 2019 (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.
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
Detailed description
Background and Rationale:
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented patches, that typically occur on the upper part of the body, especially the face. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun exposure is a triggering and accentuating factor.
PA is a common reason for dermatologic consultation due to its chronic course, frequent relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years, therefore impacting the quality of life. Emollients and mild-potency topical steroids are the mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.
Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment, another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our knowledge there is no randomized placebo-controlled trial in the literature proving the efficacy of pimecrolimus in PA.
Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA
Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis alba.
Trial design: A randomized placebo-controlled double blinded trial establishing the superiority of topical pimecrolimus 1% over placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pim | Experimental | Drug: Elidel (pimecrolimus 1%)20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed. |
| Pl | Placebo comparator | Drug: Cold Cream20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pityriasis alba Patients confirmed by a board certified dermatologist
- Age over 2 years
- Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic)
Key exclusion criteria (4 listed)
- Other concomitant dermatosis (except atopic dermatitis)
- Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks
- Known allergy to pimecrolimus
- Pregnant and nursing women
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 |
|---|---|---|
| Elidel (pimecrolimus 1%)topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed | Drug | Pim |
| Cold CreamTopical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed | Drug | Pl |
Primary outcome
Percentage of repigmentation of index lesions
Time frame: 9 weeks
Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)
4 secondary outcomes
Pruritus and scaling
Time frame: 3,6 and 9 weeks
Investigator's repigmentation change
Time frame: 3,6 and 9 weeks
patient satisfaction
Time frame: 9 weeks
Adverse events
Time frame: 3,6 and 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Pityriasis Alba
Active, not recruitingObservational study
Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
Pityriasis Alba
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. This study is not recruiting at the moment.
Josiane Helou, MD study chair
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Elidel (pimecrolimus 1%) and Cold Cream in people with Pityriasis Alba, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact elio G kechichian, MD (+9613079072, elio.kechichian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of repigmentation of index lesions (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2019.