Alopecia AreataPhase 4COLANCT02350023
Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata
A Phase 4 study testing Topical latanoprost 0.005% and Topical betamethasone 0.05% in people with Alopecia Areata, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Topical latanoprost 0.005% and Topical betamethasone 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Mar 2015
- Phase
- Phase 4
- 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 Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Cases of AA involving scalp and beard area, having 5 or less patches in all, involving less than 40% area
- Stable disease without appearance of new patch or increase in size of existing patch for at least 15 days
Who cannot join
- • Pregnant and lactating women
- Patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for alopecia in the past one month
- Presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy) or latanoprost (pregnancy, lactation and dermatitis)
- Any other coexisting hair disorder (viz., trichotillomania, androgenetic alopecia, telogen effluvium)
- Extensive disease i.e. >5 patches of AA or area involving >40% area / alopecia totalis/ alopecia universalis/ ophiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata
Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. The two agents have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.
Read the detailed description
Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. Topical prostaglandins like latanoprost have also been used for this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. However, the two agents i.e. topical corticosteroids and topical latanoprost have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- Topical latanoprost 0.005%, Topical betamethasone 0.05%
- Keywords
- alopecia areata, betamethasone, latanoprost, topical steroid, prostaglandin
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical latanoprost 0.005%Drug
Local application of the drug on affected skin/scalp
Topical betamethasone 0.05%Drug
Local application of the drug on affected skin/scalp
| Study group | Role | What they receive |
|---|---|---|
| Topical latanoprost | Active comparator | Topical latanoprost 0.005% Receives: Drug: Topical latanoprost 0.005% |
| Topical betamethasone | Active comparator | Topical betamethasone 0.05% Receives: Drug: Topical betamethasone 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hair regrowth (complete, partial, or no regrowth)
Response to the treatment in terms of hair regrowth will be assessed. The reduction in the area affected by alopecia areata will be assessed for each patient
Measured: 4 months
Secondary outcomes (1)
Number of patients suffering from adverse effects
The adverse effects of the study drugs will be assessed including erythema, pruritus, skin atrophy, dermatitis, telangiectasia, and others
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonali Bhat, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350023
- Sponsor's protocol ID
- 9121/PG-2Trg/12/8073
- Acronym
- COLA
- Status last verified
- Nov 2015
- First submitted
- 20 Jan 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhat S, Handa S, De D. A randomized comparative study of the efficacy of topical latanoprost versus topical betamethasone diproprionate lotion in the treatment of localized alopecia areata. Indian J Dermatol Venereol Leprol. 2021 Jan-Feb;87(1):42-48. doi: 10.25259/IJDVL_787_19.
PubMed 33580923
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata
- ClinicalTrials.gov ID
- NCT02350023
- Acronym / sponsor ID
- COLA / 9121/PG-2Trg/12/8073
- Conditions
- Alopecia Areata
- Keywords
- alopecia areata, betamethasone, latanoprost, topical steroid, prostaglandin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jan 2015 (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.
Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. The two agents have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.
Detailed description
Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. Topical prostaglandins like latanoprost have also been used for this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. However, the two agents i.e. topical corticosteroids and topical latanoprost have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical latanoprost | Active comparator | Drug: Topical latanoprost 0.005%Topical latanoprost 0.005% |
| Topical betamethasone | Active comparator | Drug: Topical betamethasone 0.05%Topical betamethasone 0.05% |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- • Cases of AA involving scalp and beard area, having 5 or less patches in all, involving less than 40% area
Key exclusion criteria (5 listed)
- • Pregnant and lactating 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 |
|---|---|---|
| Topical latanoprost 0.005%Local application of the drug on affected skin/scalp | Drug | Topical latanoprost |
| Topical betamethasone 0.05%Local application of the drug on affected skin/scalp | Drug | Topical betamethasone |
Primary outcome
Number of patients with hair regrowth (complete, partial, or no regrowth)
Time frame: 4 months
Response to the treatment in terms of hair regrowth will be assessed. The reduction in the area affected by alopecia areata will be assessed for each patient
1 secondary outcome
Number of patients suffering from adverse effects
Time frame: 4 months
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 2 Dec 2015.
- Derived from this study: PubMed 33580923Bhat S, Handa S, De D. A randomized comparative study of the efficacy of topical latanoprost versus topical betamethasone diproprionate lotion in the treatment of localized alopecia areata. Indian J Dermatol Venereol Leprol. 2021 Jan-Feb;87(1):42-48. doi: 10.25259/IJDVL_787_19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical latanoprost 0.005% and Topical betamethasone 0.05% in people with Alopecia Areata, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 2 inclusion and 5 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 2 Dec 2015. 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 India. 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 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?
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?
Number of patients with hair regrowth (complete, partial, or no regrowth) (time frame: 4 months). 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 NCT02350023, 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 2 Dec 2015.