Alopecia AreataPhase 3NCT01453686
A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata
A Phase 3 study testing Hydrocortisone 1% and Clobetasol Propionate 0.05% in people with Alopecia Areata, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Hydrocortisone 1% and Clobetasol Propionate 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2002to Aug 2003
- Phase
- Phase 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 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2 to 16 years
- New patients presenting to The Hospital for Sick Children
- Clinical confirmation of alopecia areata
- Hair loss between 10 -75%
Who cannot join
- Skin or medical problems requiring use of oral steroids
- Immunosuppressants or PUVA for 4 weeks prior to the study
- Use of inhaled and or intranasal steroids for 14 days prior to trial
- Topical medicaments for 7 days prior to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata
The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Two randomized controlled trials exist assessing topical steroid efficacy in this disorder, both have methodological limitations. The question remains as to which topical steroid is safe and efficacious for use. We performed a double blinded controlled trial to assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- Hydrocortisone 1%, Clobetasol Propionate 0.05%
- Keywords
- Alopecia Areata, Hydrocortisone, Clobetasol Propionate, Randomized Controlled Trial
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone 1%Drug
Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.
Clobetasol Propionate 0.05%Drug
Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone 1% | Experimental | Not described Receives: Drug: Hydrocortisone 1% |
| Clobetasol Propionate 0.05% | Experimental | Not described Receives: Drug: Clobetasol Propionate 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scalp surface area affected over time
The change in scalp surface area affected will be compared between the two intervention groups from baseline to 6 weeks, 12 weeks, and 24 weeks.
Measured: 24 weeks
Secondary outcomes (2)
Change in scalp surface area affected from baseline to end of study
The percent change in scalp surface area affected on the scalp will be compared between the intervention groups from baseline to 24 weeks.
Measured: 24 weeks
Over 50% reduction in scalp surface area affected
The number of subjects who had over 50% reduction in scalp surface area affected from baseline to 24 weeks will be compared between the intervention groups.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startAug 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Parkin, The Hospital for Sick Children
- Investigators
- Colin Macarthur, MBChB, PhD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453686
- Sponsor's protocol ID
- 0020020248
- Status last verified
- Dec 2013
- First submitted
- 13 Oct 2011
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lenane P, Macarthur C, Parkin PC, Krafchik B, DeGroot J, Khambalia A, Pope E. Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. JAMA Dermatol. 2014 Jan;150(1):47-50. doi: 10.1001/jamadermatol.2013.5764.
PubMed 24226568
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Clobetasol Propionate 0.05% Cream Versus Hydrocortisone 1% Cream in Children With Alopecia Areata
- ClinicalTrials.gov ID
- NCT01453686
- Acronym / sponsor ID
- 0020020248
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Hydrocortisone, Clobetasol Propionate, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 18 Oct 2011 (estimated)
- 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.
The use of topical steroids in the treatment of alopecia areata in children is common practice. However, no particular potency of steroid is accepted as the standard treatment due to the paucity of high quality evidence in the dermatology literature to substantiate their use. Two randomized controlled trials exist assessing topical steroid efficacy in this disorder, both have methodological limitations. The question remains as to which topical steroid is safe and efficacious for use. We performed a double blinded controlled trial to assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone 1% | Experimental | Drug: Hydrocortisone 1% |
| Clobetasol Propionate 0.05% | Experimental | Drug: Clobetasol Propionate 0.05% |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2 to 16 years
- New patients presenting to The Hospital for Sick Children
- Clinical confirmation of alopecia areata
- Hair loss between 10 -75%
Key exclusion criteria (4 listed)
- Skin or medical problems requiring use of oral steroids
- Immunosuppressants or PUVA for 4 weeks prior to the study
- Use of inhaled and or intranasal steroids for 14 days prior to trial
- Topical medicaments for 7 days prior to the trial
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 |
|---|---|---|
| Hydrocortisone 1%Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention. | Drug | Hydrocortisone 1% |
| Clobetasol Propionate 0.05%Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention. | Drug | Clobetasol Propionate 0.05% |
Primary outcome
Change in scalp surface area affected over time
Time frame: 24 weeks
The change in scalp surface area affected will be compared between the two intervention groups from baseline to 6 weeks, 12 weeks, and 24 weeks.
2 secondary outcomes
Change in scalp surface area affected from baseline to end of study
Time frame: 24 weeks
Over 50% reduction in scalp surface area affected
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Derived from this study: PubMed 24226568Lenane P, Macarthur C, Parkin PC, Krafchik B, DeGroot J, Khambalia A, Pope E. Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in children: a randomized clinical trial. JAMA Dermatol. 2014 Jan;150(1):47-50. doi: 10.1001/jamadermatol.2013.5764.
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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. This study is not recruiting at the moment.
Colin Macarthur, MBChB, PhD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortisone 1% and Clobetasol Propionate 0.05% in people with Alopecia Areata, run by The Hospital for Sick Children at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 9 Dec 2013. 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 Canada. 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scalp surface area affected over time (time frame: 24 weeks). 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 NCT01453686, which also lists 1 linked publication.
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 9 Dec 2013.